QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination... | NCT00630552 | Trialant
NCT00630552
Sponsor
NantCell, Inc.
Status
Completed
Last Update Posted
Oct 17, 2024Actual
Enrollment
138Actual
Phase
Phase 1Phase 2
Conditions
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer
Pancreatic Cancer
Interventions
Placebo
AMG 479
AMG 655
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00630552
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
20060323
Secondary IDs
ID
Type
Description
Link
QUILT-2.019
Other Identifier
NantCell, Inc.
Brief Title
QUILT-2.019: A Study of AMG 655 or AMG 479 in Combination With Gemcitabine for Treatment of Metastatic Pancreatic Cancer
Official Title
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of AMG 655 or AMG 479 in Combination With Gemcitabine as First-Line Therapy for Metastatic Pancreatic Cancer
Acronym
Not provided
Organization
NantCell, Inc.INDUSTRY
Status Module
Record Verification Date
Oct 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
Jun 2007
Primary Completion Date
Jan 2010Actual
Completion Date
Apr 2012Actual
First Submitted Date
Feb 28, 2008
First Submission Date that Met QC Criteria
Feb 28, 2008
First Posted Date
Mar 7, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 8, 2024
Results First Submitted that Met QC Criteria
Oct 14, 2024
Results First Posted Date
Oct 17, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Apr 6, 2015
Certification/Extension First Submitted that Passed QC Review
Apr 6, 2015
Certification/Extension First Posted Date
Apr 27, 2015Estimated
Last Update Submitted Date
Oct 14, 2024
Last Update Posted Date
Oct 17, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NantCell, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This is a multi-center, 2-part study of AMG 655, AMG 479 or AMG 655-placebo plus gemcitabine as first-line treatment of subjects with metastatic pancreatic cancer. Part 1 is an open-label, dose-escalation phase 1b segment to determine the safety, tolerability and maximum tolerated dose of AMG 655 in combination with gemcitabine. Enrollment into part 1 of the study has been completed. Part 2 is a randomized, placebo-controlled phase 2 segment to estimate the efficacy as assessed by 6 month survival of AMG 655, AMG 479, or AMG 655-placebo in combination with gemcitabine. The phase 2 segment that will commence after dose selection in part 1. In part 2, subjects will be randomized 1:1:1 to AMG 655, AMG 479, or placebo in combination with gemcitabine.
Detailed Description
Not provided
Conditions Module
Conditions
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer
Pancreatic Cancer
Keywords
AMG 479
Gemcitabine
TR-2
IGF-1R
AMG 655
Pancreatic cancer
Adenocarcinoma of the Pancreas
Metastatic Pancreatic Cancer
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
138Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1b AMG 655 3mg/kg
Experimental
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
Drug: AMG 655
Phase 1b AMG 655 10mg/kg
Experimental
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
Drug: AMG 655
Phase 2 AMG 655
Experimental
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
Drug: AMG 655
Phase 2 AMG 479
Experimental
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
Drug: AMG 479
Phase 2 AMG 655-placebo
Placebo Comparator
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Other
Inactive dummy of AMG 655.
Phase 2 AMG 655-placebo
AMG 479
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
28 days
Six Month Overall Survival Rate (Phase 2 Portion Only)
The proportion of subjects alive at 6 months
6 months
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate
Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Untreated metastatic adenocarcinoma of the pancreas (AJCC Stage IV)
Subjects with unresectable pancreatic cancer who have had surgery are eligible if fully recovered and greater than 30 days have elapsed since the surgery.
Subjects with a history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
Men or women ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
Adequate hematologic, hepatic, renal and coagulation function
Amylase and lipase ≤ 2.0 x ULN
Adequately controlled type 1 or 2 diabetic subjects
Exclusion Criteria:
Islet cell, acinar cell carcinoma, non-adenocarcinoma (eg, lymphoma, sarcoma, etc), adenocarcinoma originated from biliary tree or cystadenocarcinoma
Known central nervous system metastases
Uncontrolled cardiac disease or any other co-morbid disease that would increase the risk of toxicity
Cella D, Butt Z, Kindler HL, Fuchs CS, Bray S, Barlev A, Oglesby A. Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer. Qual Life Res. 2013 Jun;22(5):1105-12. doi: 10.1007/s11136-012-0217-4. Epub 2012 Jun 8.
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
FG001
Phase 1b AMG 655 10mg/kg
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
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
Nov 20, 2008
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
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Other: Placebo
Drug
AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
Phase 2 AMG 479
AMG 655
Drug
AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Phase 1b AMG 655 10mg/kg
Phase 1b AMG 655 3mg/kg
Phase 2 AMG 655
From start of study treatment through up to 36 months
Progression-free Survival (PFS)
PFS was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to the first observation of disease progression per investigator review (as classified by modified RECIST or clinical progression, whichever occurred first) or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
From start of study treatment through up to 36 months
Overall Survival
Overall survival was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to death for any cause.
From start of study treatment through up to 36 months
Number of Subjects With an Adverse Event
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
From start of study treatment through up to 44 weeks
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
PK parameter of Cmax for AMG 655 (phase 1b and phase 2 portions) - pg 266, ganitumab (phase 2 portion only) - pg 270 , and gemcitabine (phase 1b portion only - pg 272) PK parameters
From start of study treatment through up to 48 weeks
Dose Intensity of Gemcitabine (Phase 2 Portion Only)
Average Dose intensity of gemcitabine when combined with AMG 655, placebo or AMG 479
From start of study treatment through up to 40 weeks
Duration of Response
Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
From objective response through up to 36 months
Incidence of Antibody Formation
The incidence of antibody formation of anti-AMG 655 (phase 1b and phase 2 portions) or anti- ganitumab (phase 2 portion only)
From start of treatment up to 40 weeks
Bakersfield
California
93309
United States
Research Site
Fullerton
California
92835
United States
Research Site
La Jolla
California
92093
United States
Research Site
Long Beach
California
90813
United States
Research Site
Los Angeles
California
90095
United States
Research Site
Northridge
California
91328
United States
Research Site
Oxnard
California
93030
United States
Research Site
Rancho Mirage
California
92270
United States
Research Site
Redondo Beach
California
90277
United States
Research Site
San Francisco
California
94115
United States
Research Site
Santa Maria
California
93454
United States
Research Site
Santa Monica
California
90403
United States
Research Site
Miami
Florida
33136
United States
Research Site
Orlando
Florida
32804
United States
Research Site
Atlanta
Georgia
30309
United States
Research Site
Atlanta
Georgia
30341
United States
Research Site
Marietta
Georgia
30060
United States
Research Site
Chicago
Illinois
60637
United States
Research Site
Harvey
Illinois
60426
United States
Research Site
Baltimore
Maryland
21204
United States
Research Site
Westminster
Maryland
21157
United States
Research Site
Boston
Massachusetts
02114
United States
Research Site
Boston
Massachusetts
02115
United States
Research Site
St Louis
Missouri
63141
United States
Research Site
Henderson
Nevada
89052
United States
Research Site
Albany
New York
12206
United States
Research Site
New York
New York
10016
United States
Research Site
Durham
North Carolina
27710
United States
Research Site
Hickory
North Carolina
28602
United States
Research Site
Columbus
Ohio
43210
United States
Research Site
Eugene
Oregon
97401
United States
Research Site
Philadelphia
Pennsylvania
19106
United States
Research Site
Pittsburgh
Pennsylvania
15261
United States
Research Site
Providence
Rhode Island
02903
United States
Research Site
Greenville
South Carolina
29615
United States
Research Site
Austin
Texas
78705
United States
Research Site
Austin
Texas
78731
United States
Research Site
Austin
Texas
78745
United States
Research Site
Dallas
Texas
75246
United States
Research Site
Round Rock
Texas
78681
United States
Research Site
Tyler
Texas
75702
United States
Research Site
Tacoma
Washington
98405
United States
Research Site
Yakima
Washington
98902
United States
Background
Kindler HL, Richards DA, Garbo LE, Garon EB, Stephenson JJ Jr, Rocha-Lima CM, Safran H, Chan D, Kocs DM, Galimi F, McGreivy J, Bray SL, Hei Y, Feigal EG, Loh E, Fuchs CS. A randomized, placebo-controlled phase 2 study of ganitumab (AMG 479) or conatumumab (AMG 655) in combination with gemcitabine in patients with metastatic pancreatic cancer. Ann Oncol. 2012 Nov;23(11):2834-2842. doi: 10.1093/annonc/mds142. Epub 2012 Jun 13.
Background
Lu, JF.Exposure-response analysis to facilitate phase 3 dose selection for Ganitumumab (AMG 479) in combination with Gemcitabine to treat metastatic pancreatic cancer.Journal-000728;
McCaffery I, Tudor Y, Deng H, Tang R, Suzuki S, Badola S, Kindler HL, Fuchs CS, Loh E, Patterson SD, Chen L, Gansert JL. Putative predictive biomarkers of survival in patients with metastatic pancreatic adenocarcinoma treated with gemcitabine and ganitumab, an IGF1R inhibitor. Clin Cancer Res. 2013 Aug 1;19(15):4282-9. doi: 10.1158/1078-0432.CCR-12-1840. Epub 2013 Jun 5.
Background
TBD.Validation of the FACT-hepatobiliary questionnaire in metastatic pancreatic cancer population.Journal-004521;
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
FG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
FG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
FG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
FG0006 subjects
FG0017 subjects
FG00241 subjects
FG00342 subjects
FG00442 subjects
COMPLETED
FG0001 subjects
FG0010 subjects
FG0024 subjects
FG0038 subjects
FG0043 subjects
NOT COMPLETED
FG0005 subjects
FG0017 subjects
FG00237 subjects
FG00334 subjects
FG00439 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0025 subjects
FG0034 subjects
FG0042 subjects
Disease progression
FG0005 subjects
FG0016 subjects
FG00227 subjects
FG00322 subjects
FG004
Never received IP
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Ineligibility determined
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0032 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
BG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
BG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
BG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
BG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0017
BG00241
BG00342
BG00442
BG005138
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Phase 1b and Phase 2 were not analyzed together.
Mean
Standard Deviation
years
Title
Denominators
Categories
Phase 1b
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG0020
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Metastatic pancreatic cancer
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0006
ParticipantsBG0017
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs; Phase 1b Portion Only)
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
The DLT analysis set consisted of subjects in the phase 1b portion of the study only, who experienced at least 1 DLT in the first 28 days of treatment or received 2 doses of AMG 655, 3 infusions of gemcitabine in a 28 day cycle at doses not less than 750 mg/m2 and were followed for at least 28 days (with or without DLTs).
Posted
Count of Participants
Participants
28 days
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Primary
Six Month Overall Survival Rate (Phase 2 Portion Only)
The proportion of subjects alive at 6 months
Full analysis (The full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment.)
Posted
Number
95% Confidence Interval
percentage of participants
6 months
ID
Title
Description
OG000
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG002
Phase 2 AMG 655-placebo
Secondary
Objective Response Rate
Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
The Safety Analysis Set for Phase 1b (the safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received), and the Full Analysis for Phase 2 (the full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment).
Posted
Number
95% Confidence Interval
percentage of responders
From start of study treatment through up to 36 months
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Secondary
Progression-free Survival (PFS)
PFS was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to the first observation of disease progression per investigator review (as classified by modified RECIST or clinical progression, whichever occurred first) or death due to any cause, or censoring. Disease progression per RECIST is defined as at least a 20% increase in the sum of diameters of target lesions in reference to the smallest sum on study and an absolute increase of at least 5 mm; the appearance of any new lesions is also considered progression.
The Safety Analysis Set for Phase 1b (the safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received), and the Full Analysis for Phase 2 (the full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment)
Posted
Median
95% Confidence Interval
Months
From start of study treatment through up to 36 months
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Secondary
Overall Survival
Overall survival was defined as the time from study day 1 (phase 1b portion) or randomization (phase 2 portion) to death for any cause.
The Safety Analysis Set for Phase 1b (the safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received), and the Full Analysis for Phase 2 (the full analysis set consisted of all randomized subjects in the phase 2 portion of the study, with subjects analyzed according to the randomized treatment)
Posted
Median
95% Confidence Interval
Months
From start of study treatment through up to 36 months
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Secondary
Number of Subjects With an Adverse Event
Graded Using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE) Version 3.0
The safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received.
Posted
Count of Participants
Participants
From start of study treatment through up to 44 weeks
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
Secondary
Pharmacokinetics of AMG 655, Ganitumab, and Gemcitabine
PK parameter of Cmax for AMG 655 (phase 1b and phase 2 portions) - pg 266, ganitumab (phase 2 portion only) - pg 270 , and gemcitabine (phase 1b portion only - pg 272) PK parameters
The pharmacokinetic analysis set consisted of all subjects who underwent blood sampling for pharmacokinetic evaluation during the study. Cmax for AMG 655 was not calculated for the Phase 2 AMG 479 group because they did not receive AMG 655. The CMAX for AMG479 was not calculated for Phase 1b groups or the Phase 2 AMG 655 groups because they did not receive AMG 479. CMAX of gemcitabine for day 1 and day 8 were only performed in Phase 1b per protocol.
Posted
Mean
Standard Deviation
μg/mL
From start of study treatment through up to 48 weeks
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG002
Phase 2 AMG 655
Secondary
Dose Intensity of Gemcitabine (Phase 2 Portion Only)
Average Dose intensity of gemcitabine when combined with AMG 655, placebo or AMG 479
The safety analysis set consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received.
Posted
Mean
Standard Deviation
mg/m^2 /infusion
From start of study treatment through up to 40 weeks
ID
Title
Description
OG000
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG002
Secondary
Duration of Response
Duration of response was the time from the first observation of an objective response to the subsequent time of disease progression (per modified RECIST or clinical progression, whichever came first) or death due to any cause. Objective response = a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors [RECIST]. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Only subjects with a CR or PR were analyzed. Duration of response was only measured for Phase 2.
Posted
Median
Full Range
Days
From objective response through up to 36 months
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG002
Phase 2 AMG 655
Secondary
Incidence of Antibody Formation
The incidence of antibody formation of anti-AMG 655 (phase 1b and phase 2 portions) or anti- ganitumab (phase 2 portion only)
Posted
Count of Participants
Participants
From start of treatment up to 40 weeks
ID
Title
Description
OG000
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG003
Time Frame
Adverse events were measured from start of study treatment up to 44 weeks. Mortality was measured from start of treatment to up to 36 months.
Description
The safety analysis set was used for adverse events, which consisted of all subjects who received at least 1 dose of investigational product, with subjects analyzed according to the treatment received. The full population was used for mortality.
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
Phase 1b AMG 655 3mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
5
6
4
6
6
6
EG001
Phase 1b AMG 655 10mg/kg
Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
7
7
4
7
7
7
EG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
32
41
23
41
41
41
EG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
28
42
21
40
39
40
EG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
33
42
20
40
40
40
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG0030 affected40 at risk
EG0041 affected40 at risk
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0023 affected41 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Ileus
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Infusion Related Reaction
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0002 affected6 at risk
EG0011 affected7 at risk
EG0024 affected41 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Bilateral Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Pancreatic Carcinoma Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Mental Status Changes
Psychiatric disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Angina Pectoris
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Myocardial Infarction
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Optic Ischaemic Neuropathy
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Duodenal Obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Gastric Perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Obstruction Gastric
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Death
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Disease Progression
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Generalised Oedema
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Oedema Peripheral
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Bile Duct Obstruction
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Cholangitis
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Catheter Related Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Osteomyelitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Stent Occlusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Bilirubin Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Lipase Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Metabolic Acidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Primary Tumor
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Malignant Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Embolic Stroke
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hepatic Encephalopathy
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Lethargy
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Reversible Posterior Leukoencephalopathy Syndrome
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Renal Failure
Renal and urinary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Haemorrhage
Vascular disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Jugular Vein Thrombosis
Vascular disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Peripheral Embolism
Vascular disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected7 at risk
EG00212 affected41 at risk
EG0039 affected40 at risk
EG00414 affected40 at risk
Hypercoagulation
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0022 affected41 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
Systematic Assessment
EG0003 affected6 at risk
EG0010 affected7 at risk
EG00213 affected41 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0005 affected6 at risk
EG0013 affected7 at risk
EG00218 affected41 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Palpitations
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0020 affected41 at risk
EG003
Sinus Bradycardia
Cardiac disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Tinnitus
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Dry Eye
Eye disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
Systematic Assessment
EG0002 affected6 at risk
EG0015 affected7 at risk
EG0028 affected41 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0003 affected6 at risk
EG0014 affected7 at risk
EG00216 affected41 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected7 at risk
EG00211 affected41 at risk
EG003
Dry Mouth
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Ileus
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0004 affected6 at risk
EG0015 affected7 at risk
EG00214 affected41 at risk
EG003
Oesophagitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0014 affected7 at risk
EG00210 affected41 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0023 affected41 at risk
EG003
Catheter Site Haemorrhage
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Chest Pain
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0023 affected41 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0025 affected41 at risk
EG003
Early Satiety
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0005 affected6 at risk
EG0017 affected7 at risk
EG00226 affected41 at risk
EG003
Infusion Related Reaction
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Infusion Site Mass
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Infusion Site Pain
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Non-Cardiac Chest Pain
General disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Oedema Peripheral
General disorders
Systematic Assessment
EG0002 affected6 at risk
EG0012 affected7 at risk
EG00214 affected41 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0024 affected41 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0003 affected6 at risk
EG0011 affected7 at risk
EG00214 affected41 at risk
EG003
Ear Infection
Infections and infestations
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Otitis Externa
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Urinary Tract Infection
Infections and infestations
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected7 at risk
EG0022 affected41 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Skeletal Injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Stent Occlusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Ejection Fraction Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
International Normalised Ratio Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Lipase Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0023 affected41 at risk
EG003
Neutrophil Count Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Waist Circumference Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Weight Decreased
Investigations
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected7 at risk
EG0023 affected41 at risk
EG003
Weight Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Decreased Appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected6 at risk
EG0013 affected7 at risk
EG0028 affected41 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0023 affected41 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Bilateral Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0020 affected41 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0024 affected41 at risk
EG003
Flank Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Joint Swelling
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0024 affected41 at risk
EG003
Muscle Twitching
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Musculoskeletal Discomfort
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Osteolysis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0026 affected41 at risk
EG003
Pancreatic Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Pancreatic Carcinoma Metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Burning Sensation
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0024 affected41 at risk
EG003
Memory Impairment
Nervous system disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0027 affected41 at risk
EG003
Blunted Affect
Psychiatric disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Depressed Mood
Psychiatric disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0001 affected6 at risk
EG0012 affected7 at risk
EG0021 affected41 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0025 affected41 at risk
EG003
Mental Status Changes
Psychiatric disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0021 affected41 at risk
EG003
Restlessness
Psychiatric disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Bladder Neck Obstruction
Renal and urinary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Haematuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Proteinuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Renal Failure
Renal and urinary disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Urinary Hesitation
Renal and urinary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Breast Pain
Reproductive system and breast disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0020 affected41 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0003 affected6 at risk
EG0013 affected7 at risk
EG0029 affected41 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Lung Infiltration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected41 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0023 affected41 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0025 affected41 at risk
EG003
Rash Papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0025 affected41 at risk
EG003
Haematoma
Vascular disorders
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hot Flush
Vascular disorders
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0020 affected41 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected7 at risk
EG0022 affected41 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 affected6 at risk
EG0013 affected7 at risk
EG0026 affected41 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Acute Myocardial Infarction
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Angina Pectoris
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Myocardial Infarction
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Vertigo
Ear and labyrinth disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Cataract
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Eye Irritation
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Ocular Icterus
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Optic Ischaemic Neuropathy
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Photophobia
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Vision Blurred
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Visual Impairment
Eye disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Duodenal Obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Epigastric Discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Eructation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Faecal Incontinence
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Faeces Discoloured
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Gastric Perforation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Gastrointestinal Sounds Abnormal
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Gingival Pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Glossodynia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Haematochezia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hiatus Hernia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Lip Dry
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Obstruction Gastric
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Odynophagia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Oral Pain
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Pancreatic Enzyme Abnormality
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Pancreatic Insufficiency
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Sensitivity Of Teeth
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Stomatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Tooth Disorder
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Toothache
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Varices Oesophageal
Gastrointestinal disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Catheter Site Pain
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Chest Discomfort
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Death
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Disease Progression
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Gait Disturbance
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Generalised Oedema
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hernia
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Influenza Like Illness
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Infusion Site Hypersensitivity
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Injection Site Reaction
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Localised Oedema
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Malaise
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Mucosal Inflammation
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Oedema
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Temperature Intolerance
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Bile Duct Obstruction
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Cholangitis
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hepatic Failure
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Jaundice
Hepatobiliary disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Biliary Tract Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Candidiasis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Catheter Related Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Gastroenteritis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Herpes Virus Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Infected Cyst
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Localised Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Lung Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Oral Candidiasis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Oral Herpes
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Osteomyelitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Postoperative Wound Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Viral Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Incision Site Pain
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Open Wound
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Skin Laceration
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Tooth Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Alanine Aminotransferase
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Alanine Aminotransferase Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0025 affected41 at risk
EG003
Aspartate Aminotransferase
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0025 affected41 at risk
EG003
Blood Albumin Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Alkaline Phosphatase
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Blood Amylase
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Blood Amylase Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Blood Bilirubin
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Bilirubin Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Blood Calcium Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Blood Cholesterol
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Cholesterol Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Blood Creatinine
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Glucose Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Magnesium Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Potassium Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Pressure Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Sodium Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Blood Uric Acid Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Glomerular Filtration Rate Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Glucose Urine Present
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Haemoglobin
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Haemoglobin Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Heart Rate Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Lipase
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Neutrophil Count
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Platelet Count Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
White Blood Cell Count Decreased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
White Blood Cell Count Increased
Investigations
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0027 affected41 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Fluid Retention
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Gout
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hypermagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0024 affected41 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0023 affected41 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Metabolic Acidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Primary Tumor
General disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0022 affected41 at risk
EG003
Intervertebral Disc Degeneration
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Limb Discomfort
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Muscle Fatigue
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Cancer Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Choroid Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Malignant Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected41 at risk
EG003
Metastases To Liver
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected41 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG00041
OG00142
OG00242
Title
Denominators
Categories
Title
Measurements
OG00059.2(42.3 to 72.7)
OG00156.6(40.8 to 69.7)
OG00249.5(33.4 to 63.7)
OG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG0006
OG0017
OG00238
OG00339
OG00440
Title
Denominators
Categories
Title
Measurements
OG00016.67(0.42 to 64.12)
OG00114.29(0.36 to 57.87)
OG0022.63(0.07 to 13.81)
OG00310.26(2.87 to 24.22)
OG0042.50(0.06 to 13.16)
OG002
Phase 2 AMG 655
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG0006
OG0017
OG00241
OG00342
OG00442
Title
Denominators
Categories
Title
Measurements
OG0005.4(5.3 to 5.6)
OG0013.5(1.8 to 13.4)
OG0023.9(3.4 to 5.4)
OG0035.1(3.2 to 6.0)
OG0042.1(1.9 to 3.3)
OG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG0006
OG0017
OG00241
OG00342
OG00442
Title
Denominators
Categories
Title
Measurements
OG0009.0(5.6 to 17.0)
OG0018.9(6.9 to 18.5)
OG0027.5(4.8 to 10.0)
OG0038.7(5.3 to 12.2)
OG0045.9(4.1 to 9.7)
OG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG0006
OG0017
OG00241
OG00340
OG00440
Title
Denominators
Categories
Title
Measurements
OG0006
OG0017
OG00241
OG00339
OG00440
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
Units
Counts
Participants
OG0005
OG0016
OG00211
OG00313
Title
Denominators
Categories
Cmax for AMG 655
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG00211
ParticipantsOG0030
Title
Measurements
OG00055.3± 11.3
OG001198± 32.5
OG002198± 52.7
Cmax for AMG 479
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00313
Cmax for gemcitabine - Day 1
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Cmax for gemcitabine - Day 8
ParticipantsOG0005
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0030
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG00041
OG00140
OG00240
Title
Denominators
Categories
Title
Measurements
OG000861.40± 119.45
OG001906.66± 115.76
OG002936.29± 79.58
Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 655: AMG 655 is a fully human monoclonal agonist antibody directed against TRAIL Receptor 2 (TR-2).
OG003
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.
Placebo: Inactive dummy of AMG 655.
Units
Counts
Participants
OG0000
OG0010
OG0021
OG0034
OG0041
Title
Denominators
Categories
Title
Measurements
OG002301(301 to 301)
OG003253(60 to 472)
OG004116(116 to 116)
Phase 2 AMG 479
Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion.
AMG 479: AMG 479 is fully human monoclonal antagonist antibody targeted against insulin-like growth factor receptor type 1 (IGF-1R).
OG004
Phase 2 AMG 655-placebo
Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion.