Dose Escalation Trial of Dalotuzumab (MK-0646) in Advance... | NCT00701103 | Trialant
NCT00701103
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Aug 8, 2018Actual
Enrollment
80Actual
Phase
Phase 1
Conditions
Solid Tumor
Multiple Myeloma
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
NCT00701103
Obsolete or Duplicate NCT IDs
NCT00282737
Organization Study
0646-001
Secondary IDs
ID
Type
Description
Link
2007_660
Other Identifier
Merck Telerex Number
Brief Title
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
Official Title
An Open-Label, Dose Escalation Phase I Trial of MK-0646 Given as a Once Weekly, Every Other Week, or Every Three Week Infusion in Patients With Advanced Solid Tumors and Multiple Myeloma
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2018
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 12, 2006Actual
Primary Completion Date
Dec 1, 2009Actual
Completion Date
Dec 1, 2009Actual
First Submitted Date
Jun 17, 2008
First Submission Date that Met QC Criteria
Jun 18, 2008
First Posted Date
Jun 19, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 31, 2017
Results First Submitted that Met QC Criteria
Jan 31, 2017
Results First Posted Date
Mar 21, 2017Actual
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
Jul 12, 2018
Last Update Posted Date
Aug 8, 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
This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.
The hypothesis of this study is that administration of dalotuzumab as a one- to two-hour weekly, every other week, or every three week infusion in participants with advanced cancer will be generally safe and tolerated at a dose which achieves a trough concentration ≥3 μg/mL.
Detailed Description
Trial Duration of Treatment: Participants can be treated for up to two years if their disease has not progressed and they are not having unmanageable side effects.
Conditions Module
Conditions
Solid Tumor
Multiple Myeloma
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
80Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Experimental
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
Drug: Dalotuzumab
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Experimental
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Experimental
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Experimental
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Experimental
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Dalotuzumab
Drug
IV infusion
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.
Up to 3 weeks
Mean Terminal Half-life (t1/2) of Dalotuzumab
Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.
Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab
AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples
IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participant has metastatic or locally advanced solid tumor or multiple myeloma
Tumor specimen has IGF-1R expression
Participant agrees to use birth control throughout study
Exclusion Criteria:
Participant must not be recovering from antineoplastic therapy in the last 4 weeks
Participant has participated in a clinical trial in the last 4 weeks
Participant has a history of heart problems such as congestive heart failure, angina, heart attack or stroke in the last 3 months
Participant is taking growth hormone or growth hormone inhibitors
If female, participant is pregnant or breastfeeding
Participant is human immunodeficiency virus (HIV) positive
Atzori F, Tabernero J, Cervantes A, Prudkin L, Andreu J, Rodriguez-Braun E, Domingo A, Guijarro J, Gamez C, Rodon J, Di Cosimo S, Brown H, Clark J, Hardwick JS, Beckman RA, Hanley WD, Hsu K, Calvo E, Rosello S, Langdon RB, Baselga J. A phase I pharmacokinetic and pharmacodynamic study of dalotuzumab (MK-0646), an anti-insulin-like growth factor-1 receptor monoclonal antibody, in patients with advanced solid tumors. Clin Cancer Res. 2011 Oct 1;17(19):6304-12. doi: 10.1158/1078-0432.CCR-10-3336. Epub 2011 Aug 2.
Participants who were ≥18 years old, had metastatic or locally advanced solid tumors (including multiple myeloma) and failed to respond to standard therapy, or had progressed despite standard therapy, or for whom standard therapy did not exist were recruited for this study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) intravenous (IV) infusion 1 time every 1 week (Q1W).
FG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
FG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
FG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
FG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
FG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
FG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
FG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
FG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
FG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
FG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion 1 time every 3 weeks (Q3W).
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0005 subjects
FG0013 subjects
FG0028 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0068 subjects
FG0077 subjects
FG0089 subjects
FG00911 subjects
FG01011 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0013 subjects
FG0028 subjects
FG0036 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The population consisted of all participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
BG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
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
Percentage of Participants Who Experienced One or More Dose-limiting Toxicities (DLTs)
Toxicity was graded and recorded according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events version 3.0 (CTCAE 3.0). A DLT was defined as any Grade 3 or 4 toxicity. A Grade 3 toxicity was defined as severe or medically significant but not immediately life-threatening OR hospitalization or prolongation of hospitalization indicated OR disabling OR limiting self care activities of daily living. A Grade 4 toxicity was defined as: life-threatening consequences OR urgent intervention indicated. Participants were monitored for the occurrence of DLTs during the first 3 weeks of dosing with dalotuzumab.
The population consisted of all participants who received at least one dose of study drug.
Posted
Number
Percentage of Participants
Up to 3 weeks
ID
Title
Description
OG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Adverse Events Module
Frequency Threshold
5
Time Frame
Up to 30 days after last dose of study drug (Up to 25 months)
Description
The 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 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 12.1
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
Spain
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009101
Multiple Myeloma
Ancestor Terms
ID
Term
D054219
Neoplasms, Plasma Cell
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D020141
Hemostatic Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
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
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Experimental
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Experimental
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Experimental
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
Drug: Dalotuzumab
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Experimental
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion 1 time every 2 weeks (Q2W).
Drug: Dalotuzumab
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Experimental
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion1 time every 3 weeks (Q3W).
Drug: Dalotuzumab
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
MK-0646
Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
Mean Trough Serum Concentration (Ctrough) of Dalotuzumab
The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.
Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing
Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)
Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples
IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)
Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab
It is thought that 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 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).
Up to 2 years
Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND <5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.
Up to 2 years
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
6 subjects
FG0056 subjects
FG0068 subjects
FG0077 subjects
FG0089 subjects
FG00911 subjects
FG01011 subjects
1 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0100 subjects
Progressive Disease
FG0005 subjects
FG0012 subjects
FG0026 subjects
FG0035 subjects
FG0046 subjects
FG0055 subjects
FG0067 subjects
FG0077 subjects
FG0088 subjects
FG0098 subjects
FG01011 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
BG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
BG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
BG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
BG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
BG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
BG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
BG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
BG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
BG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
BG011
Total
Total of all reporting groups
5
BG0013
BG0028
BG0036
BG0046
BG0056
BG0068
BG0077
BG0089
BG00911
BG01011
BG01180
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00069± 9(59 to 81)
BG00160± 9(50 to 68)
BG00268± 9(51 to 80)
BG00356± 10(40 to 68)
BG00453± 17(26 to 70)
BG00549± 22(23 to 70)
BG00654± 18(29 to 64)
BG00746± 13(27 to 78)
BG00852± 18(22 to 69)
BG00955± 17(23 to 77)
BG01052± 15(19 to 73)
BG01155± 16(19 to 81)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0011
BG0024
BG0036
BG0043
BG0053
BG0064
BG0072
BG0085
BG0095
BG0106
BG01140
Male
BG0004
BG0012
BG0024
BG0030
BG004
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG0036
OG0046
OG0056
OG0068
OG0077
OG0089
OG00911
OG01011
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG00213
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
Primary
Mean Terminal Half-life (t1/2) of Dalotuzumab
Terminal half-life is defined as the time it takes for the blood plasma concentration of a substance to halve (plasma half-life). Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion. Data presented are for the harmonic mean t1/2 for dalotuzumab.
The population consisted of all evaluable participants who received >90% of intended drug volume and had t1/2 pharmacokinetic measurements at Baseline and at least once during treatment.
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00067(46 to 121)
OG00179(53 to 113)
OG00283(41 to 240)
OG003
Primary
Area Under the Time-concentration Curve From 0 to Infinity Hours (AUC0-∞) of Dalotuzumab
AUC0-∞ represents the total drug exposure over time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: Predose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post-infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
The population consisted of all evaluable participants who received >90% of intended drug volume and had AUC0-last pharmacokinetic measurements at Baseline and at least once during treatment.
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.6± 0.4
OG0013.7± 1.1
OG00212.9± 4.4
OG003
Primary
Mean Serum Clearance of Dalotuzumab
Clearance is defined as the volume of serum from which study drug was completely removed per unit of time. Blood samples for measurement of serum levels of dalotuzumab were obtained at: pre-dose; pre-end infusion; 0.5, 5, 10, 24, 30 (Q1W only), 48, 96, 168 (Q2W/Q3W only), 336 (Q3W only) hours post infusion. For infusions >1 hour in duration, an additional sample was obtained at the mid-point of the infusion.
The population consisted of all evaluable participants who received >90% of intended drug volume and had mean serum clearance pharmacokinetic measurements at Baseline and at least once during treatment.
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.013± 0.004
OG0010.012± 0.003
OG0020.007± 0.003
OG003
Primary
Mean Trough Serum Concentration (Ctrough) of Dalotuzumab
The lowest (trough) concentration of dalotuzumab prior to the next dose of dalotuzumab was measured.
The population consisted of all evaluable participants who received >90% of intended drug volume and had mean trough serum concentration pharmacokinetic measurements at Baseline and at least once during treatment.
Posted
Mean
Standard Deviation
ug/mL
Pre-dose immediately prior to second infusion: 168 hours for Q1W, 336 hours for Q2W and 504 hours for Q3W dosing
ID
Title
Description
OG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0002.4± 2.2
OG0017.2± 3.0
OG00221.2± 8.3
OG003
Secondary
Change From Baseline in Insulin-like Growth Factor Receptor Type 1 (IGF-1R) Protein Expression Level H-score in Skin Samples
IGF-1R expression was measured in pre- and post-dose skin biopsy samples using an immunohistochemistry (IHC) assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
The population consisted of all evaluable participants who received >90% of intended drug volume and had skin IGF-1R pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 30 mg/kg Q3W treatment group.
Posted
Mean
Standard Deviation
H-score
Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)
ID
Title
Description
OG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
OG004
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
OG005
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
OG006
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0003
OG0013
OG0027
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000186.7± 35.1
OG001203.3± 55.1
OG002218.6± 57.9
OG003
Secondary
Change From Baseline in IGF-1R Protein Expression Level H-score in Tumor Samples
IGF-1R expression was measured in pre- and post-dose tumor biopsy samples using an IHC assay as a function of time and dose. Results were expressed as an IGF-1R membrane H-score which could range from 0 to 300; with a score of 0 representing the absence of IGF-1R expression and an H-score of 300 representing maximum IGF-1R expression. Changes in IGF-1R expression levels from Baseline are summarized for all participants for whom these paired data were available. A post-dose decrease in IGF-1R membrane H-score was an indication of target engagement by dalotuzumab. A larger decrease in H-score correlated with a greater target engagement.
The population consisted of all evaluable participants who received >90% of intended drug volume and had IGF-1R tumor pharmacodynamics measurements at Baseline and at least once during treatment. No data were available for the Dalotuzumab 2.5 mg/kg Q1W and Dalotuzumab 30 mg/kg Q3W treatment groups.
Posted
Mean
Standard Deviation
H-score
Predose in Cycle 1 (Baseline) and predose in Cycle 3 (Week 4)
ID
Title
Description
OG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg IV infusion Q1W.
OG004
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg IV infusion Q1W.
OG005
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg IV infusion Q1W or Q2W.
OG006
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0002
OG0010
OG0025
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG000145.0± 91.9
OG00284.0± 59.0
OG003110.0± 46.9
OG004
Secondary
Percentage of Participants Who Developed a Serum Human-anti-humanized-antibody (HAHA) Response to Dalotuzumab
It is thought that 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 2 (Q1W), pre-dose Week 3 (Q2W), pre-dose Week 4 (QW3), pre-dose Week 5 (Q1W/Q2W), pre-dose Week 7 (Q2W/Q3W), pre-dose Week 9 (Q2W), pre-dose Week 10 (QW3) and pre-dose every 4 subsequent weeks and end of treatment (post-study: 4 weeks after last dose of study drug).
The population consisted of all participants who received >90% of intended drug volume and had measurements at Baseline and at least once during treatment.
Posted
Number
Percentage of Participants
Up to 2 years
ID
Title
Description
OG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00040
OG0010
OG0020
OG003
Secondary
Percentage of Participants Who Experienced a Complete Response (CR) or Partial Response (PR)
Tumor responses were measured by using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in participants with solid tumors and using European Group for Blood and Marrow Transplantation (EBMT) criteria in participants with multiple myeloma. RECIST criteria for CR: Disappearance of all target lesions. RECIST criteria for PR: ≥30% decrease in the sum of diameters of target lesions. EBMT criteria for CR: Disappearance of the original mAb protein from the blood and urine AND <5% plasma cells in the bone marrow AND no increase in the size or number of lytic bone lesions AND disappearance of soft tissue plasmacytomas AND normal serum calcium levels. EMBT criteria for PR: ≥50% reduction in the serum mAb protein level AND if a urine M-component is present, a reduction in 24-hour urinary light chain excretion by either ≥90% or to <200 mg AND ≥50% reduction in the size of soft tissue plasmacytomas AND no increase in size or number of lytic bone lesions.
The population consisted of all evaluable participants who received >90% of intended drug volume and had efficacy measurements at Baseline and at least once during treatment.
Posted
Number
Percentage of Participants
Up to 2 years
ID
Title
Description
OG000
Dalotuzumab 1.25 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 1.25 mg/kg (10 mg/mL) IV infusion Q1W.
OG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
OG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
OG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
OG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
OG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
OG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/ mL) IV infusion Q1W.
OG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
OG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20.0 mg/kg (20 mg/mL) IV infusion Q1W.
OG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
OG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
Units
Counts
Participants
OG0005
OG0013
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
0
5
5
5
EG001
Dalotuzumab 2.5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 2.5 mg/kg (10 mg/mL) IV infusion Q1W.
0
3
3
3
EG002
Dalotuzumab 5 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 5 mg/kg (10 mg/mL) IV infusion Q1W.
2
8
6
8
EG003
Dalotuzumab 10 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 10 mg/kg (10 mg/mL) IV infusion Q1W.
2
6
5
6
EG004
Dalotuzumab 10 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 10 mg/kg (20 mg/mL) IV infusion Q1W.
2
6
4
6
EG005
Dalotuzumab 15 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 15 mg/kg (10 mg/mL) IV infusion Q1W.
3
6
5
6
EG006
Dalotuzumab 15 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 15 mg/kg (20 mg/mL) IV infusion Q1W.
3
8
8
8
EG007
Dalotuzumab 20 mg/kg Q1W (10 mg/mL)
Participants received dalotuzumab 20 mg/kg (10 mg/mL) IV infusion Q1W.
0
7
6
7
EG008
Dalotuzumab 20 mg/kg Q1W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q1W.
2
9
8
9
EG009
Dalotuzumab 20 mg/kg Q2W (20 mg/mL)
Participants received dalotuzumab 20 mg/kg (20 mg/mL) IV infusion Q2W.
3
11
9
11
EG010
Dalotuzumab 30 mg/kg Q3W (20 mg/mL)
Participants received dalotuzumab 30 mg/kg (20 mg/mL) IV infusion Q3W.
1
11
11
11
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Pancreatitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Subileus
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Asthenia
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Skin bacterial infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Femur fracture
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Ewing's sarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Convulsion
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0032 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Spinal cord compression
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Renal failure acute
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Leukocytoclastic vasculitis
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Deep vein thrombosis
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0044 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Lymph node pain
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0082 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Tinnitus
Ear and labyrinth disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Diplopia
Eye disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0013 events1 affected3 at risk
EG0022 events2 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0052 events2 affected6 at risk
EG0061 events1 affected8 at risk
EG0073 events2 affected7 at risk
EG0082 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0022 events1 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Constipation
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0091 events1 affected11 at risk
EG0102 events2 affected11 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0104 events2 affected11 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0102 events2 affected11 at risk
Nausea
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0092 events1 affected11 at risk
EG0105 events3 affected11 at risk
Odynophagia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Oesophagitis
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Proctalgia
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Toothache
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Vomiting
Gastrointestinal disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0092 events2 affected11 at risk
EG0104 events2 affected11 at risk
Asthenia
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events2 affected3 at risk
EG0025 events4 affected8 at risk
EG0033 events2 affected6 at risk
EG0042 events2 affected6 at risk
EG0050 events0 affected6 at risk
EG0065 events3 affected8 at risk
EG0073 events2 affected7 at risk
EG0082 events2 affected9 at risk
EG0093 events3 affected11 at risk
EG0106 events5 affected11 at risk
Chest pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0032 events2 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Chills
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Fatigue
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Infusion related reaction
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Mucosal inflammation
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Oedema peripheral
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Pain
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Pyrexia
General disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0002 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Jaundice
Hepatobiliary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Bronchiectasis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Nasopharyngitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Pharyngitis
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Respiratory tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Urinary tract infection
Infections and infestations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0005 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Wound
Injury, poisoning and procedural complications
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Alanine aminotransferase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0102 events2 affected11 at risk
Aspartate aminotransferase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0002 events2 affected5 at risk
EG0010 events0 affected3 at risk
EG0024 events3 affected8 at risk
EG0032 events1 affected6 at risk
EG0043 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events2 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0102 events2 affected11 at risk
Blood alkaline phosphatase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Blood bilirubin increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Blood cholesterol increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0102 events1 affected11 at risk
Blood creatinine increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0043 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Blood glucose decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Blood glucose increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0085 events2 affected9 at risk
EG0092 events2 affected11 at risk
EG0100 events0 affected11 at risk
Blood triglycerides increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0102 events1 affected11 at risk
Gamma-glutamyltransferase increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Haemoglobin decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Platelet count decreased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Transaminases increased
Investigations
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Anorexia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0063 events2 affected8 at risk
EG0070 events0 affected7 at risk
EG0085 events4 affected9 at risk
EG0090 events0 affected11 at risk
EG0102 events2 affected11 at risk
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0024 events2 affected8 at risk
EG0033 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0056 events3 affected6 at risk
EG0063 events2 affected8 at risk
EG0072 events1 affected7 at risk
EG0084 events3 affected9 at risk
EG0093 events1 affected11 at risk
EG0102 events2 affected11 at risk
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0102 events2 affected11 at risk
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0028 events3 affected8 at risk
EG0031 events1 affected6 at risk
EG0042 events2 affected6 at risk
EG0052 events1 affected6 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0104 events3 affected11 at risk
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0044 events3 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0102 events1 affected11 at risk
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Infected neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Dizziness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Dysgeusia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Headache
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0091 events1 affected11 at risk
EG0102 events2 affected11 at risk
Loss of consciousness
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Paraesthesia
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Somnolence
Nervous system disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Anxiety
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0101 events1 affected11 at risk
Confusional state
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0032 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Depression
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Insomnia
Psychiatric disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Dysuria
Renal and urinary disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Pelvic pain
Reproductive system and breast disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0062 events1 affected8 at risk
EG0072 events2 affected7 at risk
EG0081 events1 affected9 at risk
EG0091 events1 affected11 at risk
EG0102 events1 affected11 at risk
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected7 at risk
EG0086 events3 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Increased upper airway secretion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0031 events1 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0102 events1 affected11 at risk
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0091 events1 affected11 at risk
EG0100 events0 affected11 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0101 events1 affected11 at risk
Rash
Skin and subcutaneous tissue disorders
MedDRA 12.1
Systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Hypertension
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected8 at risk
EG0071 events1 affected7 at risk
EG0081 events1 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 at risk
Lymphoedema
Vascular disorders
MedDRA 12.1
Systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected8 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected9 at risk
EG0090 events0 affected11 at risk
EG0100 events0 affected11 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.