A Dose-finding Study of Dalotuzumab in Subjects With Adva... | NCT00635778 | Trialant
NCT00635778
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Oct 9, 2018Actual
Enrollment
50Actual
Phase
Phase 1
Conditions
Advanced Solid Tumors
Interventions
dalotuzumab
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00635778
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
0646-002
Secondary IDs
ID
Type
Description
Link
MK-0646-002
Other Identifier
Merck Protocol Number
Brief Title
A Dose-finding Study of Dalotuzumab in Subjects With Advanced Solid Tumors (MK-0646-002)
Official Title
An Open-Label, Dose Escalation Phase I Trial of MK-0646 Given as a One to Two Hour Every Other Week Infusion in Patients With Relapsed or Refractory Locally Advanced or Metastatic Cancers
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 7, 2006Actual
Primary Completion Date
Nov 5, 2008Actual
Completion Date
Nov 5, 2008Actual
First Submitted Date
Feb 29, 2008
First Submission Date that Met QC Criteria
Mar 7, 2008
First Posted Date
Mar 14, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 26, 2018
Results First Submitted that Met QC Criteria
Feb 26, 2018
Results First Posted Date
Oct 9, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 26, 2018
Last Update Posted Date
Oct 9, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study determined the recommended Phase 2 loading and maintenance doses and dose schedules for administering dalotuzumab using dose-limiting toxicities (DLTs) observed during the entire treatment period (Up to 18 months). The primary hypothesis of the study was that administration of dalotuzumab as an every other week infusion in participants with relapsed or refractory locally advanced or metastatic cancers associated with a high frequency of insulin-like growth factor receptor type 1(IGF-1R) overexpression will be generally safe and well tolerated to permit further study and achieve a constant clearance and a minimum trough concentration of 3 µg/mL.
Detailed Description
The study consisted of 3 parts. In Part 1 the loading dose was escalated while the maintenance dose was kept constant. In Part 2 the loading dose was kept constant while the maintenance dose was escalated. In Part 3 the recommended phase 2 loading and maintenance doses and schedule were administered to an expanded cohort to explore safety and efficacy of dalotuzumab.
Conditions Module
Conditions
Advanced Solid Tumors
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
dalotuzumab 2.5/2.5 mg/kg
Experimental
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
dalotuzumab 5.0/5.0 mg/kg
Experimental
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
dalotuzumab 10.0/5.0 mg/kg
Experimental
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
dalotuzumab 15.0/5.0mg/kg
Experimental
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
dalotuzumab
Drug
Administered as an IV infusion over one to two hours
dalotuzumab 10.0/5.0 mg/kg
dalotuzumab 15.0/10.0 mg/kg
dalotuzumab 15.0/15.0 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose
Blood samples were obtained for analysis of steady-state serum concentration of dalotuzumab at 336 hours (C336) after the first maintenance dose of dalotuzumab. The C336 of dalotuzumab after intravenous administration is presented.
2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)
Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLT) were assessed and graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE). A DLT was defined as the occurrence of any of the following events, that were judged by the study investigator, to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5 degrees Celsius; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity (except alopecia and inadequately treated diarrhea, nausea, and vomiting, and hyperglycemia lasting less than 5 days; and Grade 3 or greater hyperglycemia lasting for more than 5 days in spite of optimal medical management.
The entire treatment period (Up to 18 months)
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
Complete Response (disappearance of all target lesions) or Partial Response (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) using Response Criteria in Solid Tumors (RECIST). Tumor response was assessed prior to first dose and every 8 weeks beginning pre-dose of Week 9 for up to 18 months. The best response out of all measurements for each participant was used for determining CR and PR.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males and females with advanced solid tumors who have failed to respond to standard therapy, ages 18 years and older, with adequate organ function
Exclusion Criteria:
Participant is using growth hormones or growth hormone inhibitors
Participant is known to be allergic to components of the drug or similar drugs (e.g. monoclonal antibodies such as rituximab or biological therapies such as immunoglobulin G
Participant has had chemotherapy, radiotherapy, or biological therapy within 4-6 weeks of entering the study or has not recovered from previous therapy
Participant is taking part in or has taken part in a study of an investigational compound or device within 30 days of their first dose of study drug
Participant has an active Central Nervous System metastases and/or carcinomatous meningitis. However, a participant who has completed a course of therapy and is clinically stable may be able to participate
Participant is pregnant or breastfeeding
Participant is human immunodeficiency virus (HIV) positive
Participant has a history of Hepatitis B or C
Participant has symptomatic ascites or pleural effusion. However, if the participant has received treatment and is stable, they may be able to participate
Female participant plans to become pregnant or a male participant who plans to impregnate their partner during the time the study is ongoing
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Not provided
Recruitment Details
This study enrolled participants with metastatic or locally advanced solid tumors, associated with insulin-like growth factor receptor type 1 (IGF-1R) protein expression, that have failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist. Other inclusion/exclusion criteria applied.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by intravenous (IV) infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
FG001
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
FG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
FG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
FG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
FG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
FG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0038 subjects
FG0048 subjects
FG00521 subjects
FG0066 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0023 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Steady-state Serum Concentration of Dalotuzumab at 336 Hours (C336) After the First Maintenance Dose
Blood samples were obtained for analysis of steady-state serum concentration of dalotuzumab at 336 hours (C336) after the first maintenance dose of dalotuzumab. The C336 of dalotuzumab after intravenous administration is presented.
All participants who received dalotuzumab and had blood samples drawn for pharmacokinetic (PK) analyses.
Posted
Mean
Standard Deviation
μg/mL
2 weeks post first maintenance dose of study drug (3 weeks post loading dose of study drug)
ID
Title
Description
OG000
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 19 months (up to 18 months of treatment with study drug plus 1 month of follow-up)
Description
The safety population consisted of all participants who received at least one dose of study drug.
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
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
Jul 10, 2026
Removed Countries
Puerto Rico
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
ID
Term
C569480
dalotuzumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
dalotuzumab 20.0/5.0 mg/kg
Experimental
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
dalotuzumab 15.0/10.0 mg/kg
Experimental
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
dalotuzumab 15.0/15.0 mg/kg
Experimental
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Drug: dalotuzumab
dalotuzumab 15.0/5.0mg/kg
dalotuzumab 2.5/2.5 mg/kg
dalotuzumab 20.0/5.0 mg/kg
dalotuzumab 5.0/5.0 mg/kg
MK-0646
Up to 18 months post first dose of study drug
Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 1
Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer
The formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 3, Week 5, pre-dose every 8 subsequent weeks, and end of treatment (post-study: 4 weeks after last dose of study drug). Positive HAHA status for a participant is defined as testing positive on both the screening and immunodepletion assays at one or more visits.
Prior to second and subsequent doses of study drug (Up to 1 year post-first dose)
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 5
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 9
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 13
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 17
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 21
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 25
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 29
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 33
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 37
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 41
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 45
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 49
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
Baseline and Week 53
0 subjects
FG0050 subjects
FG0060 subjects
8 subjects
FG00521 subjects
FG0066 subjects
3 subjects
FG0043 subjects
FG0056 subjects
FG0061 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
Progressive disease
FG0000 subjects
FG0013 subjects
FG0023 subjects
FG0034 subjects
FG0045 subjects
FG00514 subjects
FG0064 subjects
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
BG007
Total
Total of all reporting groups
1
BG0013
BG0023
BG0038
BG0048
BG00521
BG0066
BG00750
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00062.0± NANot calculated for only 1 participant
BG00174.3± 9.9
BG00260.3± 8.6
BG00371.3± 6.5
BG00459.1± 7.6
BG00558.1± 11.8
BG00653.7± 21.2
BG00761.0± 12.7
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG0022
BG0031
BG0041
BG00510
BG0062
BG00717
Male
BG0001
BG0012
BG0021
BG0037
BG004
Race (NIH/OMB)
The race of participants is presented.
All enrolled participants.
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0021
BG0031
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0030
BG004
White
BG0001
BG0013
BG0022
BG0036
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0031
BG004
Number of Prior Chemotherapy Regimens
Mean
Standard Deviation
Regimens
Title
Denominators
Categories
Title
Measurements
BG0003.0± NANot calculated on only 1 participant
BG0012.7± 0.6
BG0023.0± 0.0
BG0033.0± 0.0
BG0043.0± 0.0
BG0052.9± 0.3
BG0062.5± 0.8
BG0072.9± 0.4
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Participants were assessed for ECOG PS: Grade 0: Fully active, able to carry on all pre-disease performance without restriction; Grade 1: Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature; Grade 2: Ambulatory & capable of all self-care but unable to carry out any work activities, up & about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; Grade 4: Completely disabled, cannot carry on any self-care, totally confined to bed or chair or Grade 5: Dead.
All enrolled participants
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
ECOG PS = 0
BG0000
BG0011
BG0021
BG0031
BG0043
BG00510
BG0064
BG00720
ECOG PS = 1
BG0000
BG0012
BG0022
BG0036
BG004
ECOG PS = 2
BG0001
BG0010
BG0020
BG0031
BG004
OG001
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
OG0012
OG0023
OG0036
OG0048
OG00519
OG0065
Title
Denominators
Categories
Title
Measurements
OG0004.78± NANot calculated on only 1 participant
OG0017.48± 8.50
OG00254.57± 24.64
OG00333.00± 24.90
OG00425.95± 26.22
OG00524.39± 27.63
OG00686.73± 44.56
Primary
Number of Participants Who Experience One or More Dose- Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLT) were assessed and graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE). A DLT was defined as the occurrence of any of the following events, that were judged by the study investigator, to be related to the study medication: Grade 4 neutropenia; Grade 3 neutropenia with fever >38.5 degrees Celsius; Grade 4 thrombocytopenia; Grade 3 or Grade 4 non-hematologic toxicity (except alopecia and inadequately treated diarrhea, nausea, and vomiting, and hyperglycemia lasting less than 5 days; and Grade 3 or greater hyperglycemia lasting for more than 5 days in spite of optimal medical management.
All participants who received at least one dose of study drug.
Posted
Count of Participants
Participants
The entire treatment period (Up to 18 months)
ID
Title
Description
OG000
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG001
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Number of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
Complete Response (disappearance of all target lesions) or Partial Response (at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) using Response Criteria in Solid Tumors (RECIST). Tumor response was assessed prior to first dose and every 8 weeks beginning pre-dose of Week 9 for up to 18 months. The best response out of all measurements for each participant was used for determining CR and PR.
All participants who received at least one dose of study therapy.
Posted
Count of Participants
Participants
Up to 18 months post first dose of study drug
ID
Title
Description
OG000
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG001
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Percent Change From Baseline in Serum Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Level at Week 1
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 1.
Posted
Median
Full Range
Percent change
Baseline and Week 1
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG00041
Title
Denominators
Categories
Title
Measurements
OG000118.56(-61.54 to 377.08)
Secondary
Number of Participants With a Positive Human-anti-humanized-antibody (HAHA) Titer
The formation of HAHAs may block efficacy by prematurely clearing dalotuzumab and limit the possibility of future dalotuzumab therapy. Blood samples for the measurement of serum levels of HAHAs were obtained prior to treatment with dalotuzumab, and pre-dose Week 3, Week 5, pre-dose every 8 subsequent weeks, and end of treatment (post-study: 4 weeks after last dose of study drug). Positive HAHA status for a participant is defined as testing positive on both the screening and immunodepletion assays at one or more visits.
All participants who received one dose of study therapy.
Posted
Count of Participants
Participants
Prior to second and subsequent doses of study drug (Up to 1 year post-first dose)
ID
Title
Description
OG000
Dalotuzumab 2.5 mg/kg / Dalotuzumab 2.5 mg/kg
Participants received a loading dose of dalotuzumab 2.5 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 2.5 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG001
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
OG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 5
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 5
Posted
Median
Full Range
Percent change
Baseline and Week 5
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG00025
Title
Denominators
Categories
Title
Measurements
OG000150.94(-49.35 to 421.84)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 9
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 9
Posted
Median
Full Range
Percent change
Baseline and Week 9
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG000150.69(55.00 to 246.51)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 13
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 13
Posted
Median
Full Range
Percent change
Baseline and Week 13
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG000138.11(128.42 to 164.29)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 17
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 17
Posted
Median
Full Range
Percent change
Baseline and Week 17
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0003
Title
Denominators
Categories
Title
Measurements
OG000140.72(120.00 to 198.05)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 21
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 21
Posted
Median
Full Range
Percent change
Baseline and Week 21
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0003
Title
Denominators
Categories
Title
Measurements
OG000150.00(102.40 to 161.05)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 25
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 25
Posted
Median
Full Range
Percent change
Baseline and Week 25
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0003
Title
Denominators
Categories
Title
Measurements
OG000157.49(114.74 to 170.78)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 29
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 29
Posted
Median
Full Range
Percent change
Baseline and Week 29
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0002
Title
Denominators
Categories
Title
Measurements
OG000174.95(172.63 to 177.27)
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 33
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 33
Posted
Median
Full Range
Percent change
Baseline and Week 33
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG000158.95(NA to NA)Not calculated on only 1 participant
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 37
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 37
Posted
Median
Full Range
Percent change
Baseline and Week 37
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG000186.32(NA to NA)Not calculated on only 1 participant
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 41
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 41
Posted
Median
Full Range
Percent change
Baseline and Week 41
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG000173.68(NA to NA)Not calculated on only 1 participant
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 45
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 45
Posted
Median
Full Range
Percent change
Baseline and Week 45
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG000140.00(NA to NA)Not calculated on only 1 participant
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 49
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 49
Posted
Median
Full Range
Percent change
Baseline and Week 49
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG000137.89(NA to NA)Not calculated on only 1 participant
Secondary
Percent Change From Baseline in Serum IGF-1R Protein Level at Week 53
IGF-1R expression was measured in pre- and post-dose biopsy samples using immunohistochemistry (IHC) and enzyme-linked immunosorbent assay (ELISA) assays. Results were expressed as a percent change from baseline in IG1-FR expression for participants pooled across all dose arms in the study and calculated by study week. A post-dose decrease in IGF-1R expression was an indication of target engagement by dalotuzumab. A larger percent change correlated with a greater target engagement.
All participants who took at least one dose of study drug and had available IGF-1R protein data for Baseline and Week 53
Posted
Median
Full Range
Percent change
Baseline and Week 53
ID
Title
Description
OG000
Pooled Participants Who Received Dalotuzumab
Participants were pooled from all dose arms in the study. Participants received a loading dose of dalotuzumab administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab administered by IV infusion every two weeks for up to 18 months.
Units
Counts
Participants
OG0001
Title
Denominators
Categories
Title
Measurements
OG000198.99(NA to NA)Not calculated on only 1 participant
0
1
1
1
1
1
EG001
Dalotuzumab 5.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 5.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
1
3
2
3
3
3
EG002
Dalotuzumab 10.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 10.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
0
3
2
3
3
3
EG003
Dalotuzumab 15.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
1
8
5
8
8
8
EG004
Dalotuzumab 20.0 mg/kg / Dalotuzumab 5.0 mg/kg
Participants received a loading dose of dalotuzumab 20.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 5.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
1
8
6
8
8
8
EG005
Dalotuzumab 15.0 mg/kg / Dalotuzumab 10.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 10.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
1
21
9
21
21
21
EG006
Dalotuzumab 15.0 mg/kg / Dalotuzumab 15.0 mg/kg
Participants received a loading dose of dalotuzumab 15.0 mg/kg administered by IV infusion. Two weeks following completion of the loading dose, participants received a maintenance dose of dalotuzumab 15.0 mg/kg administered by IV infusion every two weeks for up to 18 months.
1
6
3
6
6
6
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Haematemesis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Obstruction gastric
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Infusion related reaction
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Bile duct obstruction
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Cholangitis
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Abdominal abscess
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Cellulitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Osteomyelitis acute
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Sepsis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Device failure
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Incisional hernia
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Oesophageal carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Cerebrovascular accident
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Encephalopathy
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Lethargy
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Mental status changes
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Bladder pain
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Haematuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Ureteric obstruction
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Alveolitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
EG0001 events1 affected1 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG0032 events2 affected8 at risk
EG0042 events2 affected8 at risk
EG0056 events6 affected21 at risk
EG0061 events1 affected6 at risk
Coagulopathy
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Bradycardia
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Cardiac failure congestive
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Palpitations
Cardiac disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Deafness
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Vertigo
Ear and labyrinth disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Dry eye
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0061 events1 affected6 at risk
Myodesopsia
Eye disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events2 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0042 events2 affected8 at risk
EG0055 events4 affected21 at risk
EG0061 events1 affected6 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Ascites
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Constipation
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0012 events2 affected3 at risk
EG0022 events1 affected3 at risk
EG0032 events2 affected8 at risk
EG0042 events2 affected8 at risk
EG0054 events4 affected21 at risk
EG0061 events1 affected6 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected3 at risk
EG0031 events1 affected8 at risk
EG0043 events3 affected8 at risk
EG0053 events3 affected21 at risk
EG0061 events1 affected6 at risk
Dry mouth
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0062 events2 affected6 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Epigastric discomfort
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Flatulence
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Haemorrhoids
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Melaena
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Nausea
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0013 events2 affected3 at risk
EG0023 events2 affected3 at risk
EG0031 events1 affected8 at risk
EG0042 events2 affected8 at risk
EG00510 events10 affected21 at risk
EG0062 events2 affected6 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Stomatitis
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Vomiting
Gastrointestinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected3 at risk
EG0032 events2 affected8 at risk
EG0042 events2 affected8 at risk
EG00510 events7 affected21 at risk
EG0062 events2 affected6 at risk
Asthenia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0061 events1 affected6 at risk
Chest pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Chills
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Fatigue
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected3 at risk
EG0037 events4 affected8 at risk
EG0043 events3 affected8 at risk
EG00512 events12 affected21 at risk
EG0064 events4 affected6 at risk
Hernia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Infusion related reaction
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Oedema
General disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Oedema peripheral
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected8 at risk
EG0041 events1 affected8 at risk
EG0053 events3 affected21 at risk
EG0060 events0 affected6 at risk
Pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0054 events3 affected21 at risk
EG0062 events2 affected6 at risk
Pyrexia
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Suprapubic pain
General disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0054 events4 affected21 at risk
EG0060 events0 affected6 at risk
Portal vein occlusion
Hepatobiliary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Body tinea
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Candidiasis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Ear infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Fungal oesophagitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Influenza
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Osteomyelitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Otitis externa
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Sinusitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Skin infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Urinary tract infection
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Foot fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Skin laceration
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Activated partial thromboplastin time prolonged
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Alanine aminotransferase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0042 events1 affected8 at risk
EG0055 events3 affected21 at risk
EG0060 events0 affected6 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0044 events2 affected8 at risk
EG0055 events3 affected21 at risk
EG0060 events0 affected6 at risk
Blood albumin decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0053 events2 affected21 at risk
EG0060 events0 affected6 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0043 events3 affected8 at risk
EG0056 events4 affected21 at risk
EG0060 events0 affected6 at risk
Blood creatinine increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0063 events2 affected6 at risk
Blood glucose increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected21 at risk
EG0061 events1 affected6 at risk
Blood lactate dehydrogenase increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Blood magnesium decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Blood magnesium increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Blood uric acid increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Glomerular filtration rate decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0061 events1 affected6 at risk
Haemoglobin urine present
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0061 events1 affected6 at risk
International normalised ratio increased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Platelet count decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Prothrombin time prolonged
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Weight decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected3 at risk
EG0033 events3 affected8 at risk
EG0045 events4 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
White blood cell count decreased
Investigations
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Acidosis
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Anorexia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0056 events6 affected21 at risk
EG0061 events1 affected6 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0054 events4 affected21 at risk
EG0060 events0 affected6 at risk
Hyperammonaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Hypercreatininaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0033 events2 affected8 at risk
EG0041 events1 affected8 at risk
EG0056 events4 affected21 at risk
EG0060 events0 affected6 at risk
Hypermagnesaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0003 events1 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0053 events3 affected21 at risk
EG0062 events2 affected6 at risk
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Lumbar spinal stenosis
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events1 affected21 at risk
EG0061 events1 affected6 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Ageusia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Asterixis
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Ataxia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Balance disorder
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Dizziness
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Headache
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0060 events0 affected6 at risk
Memory impairment
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Neuropathy peripheral
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0061 events1 affected6 at risk
Paraesthesia
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0051 events1 affected21 at risk
EG0061 events1 affected6 at risk
Somnolence
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Syncope
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Tremor
Nervous system disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Agitation
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Confusional state
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Depression
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Insomnia
Psychiatric disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Haematuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Polyuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Proteinuria
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0060 events0 affected6 at risk
Renal failure
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Ureteric stenosis
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Urinary incontinence
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Urinary retention
Renal and urinary disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Breast pain
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Penile pain
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Scrotal oedema
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Sexual dysfunction
Reproductive system and breast disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0061 events1 affected6 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0041 events1 affected8 at risk
EG0055 events5 affected21 at risk
EG0061 events1 affected6 at risk
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0061 events1 affected6 at risk
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0032 events2 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Lung infiltration
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Pulmonary cavitation
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0052 events2 affected21 at risk
EG0061 events1 affected6 at risk
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0061 events1 affected6 at risk
Rash follicular
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0041 events1 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0000 events0 affected1 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
Hypotension
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0051 events1 affected21 at risk
EG0062 events2 affected6 at risk
Lymphorrhoea
Vascular disorders
MedDRA 12.0
Systematic Assessment
EG0001 events1 affected1 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected21 at risk
EG0060 events0 affected6 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.