GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
Official Title
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors
Acronym
Not provided
Organization
GenmabINDUSTRY
Status Module
Record Verification Date
Jul 2023
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Sponsor decision
Expanded Access Info
No
Start Date
Apr 30, 2018Actual
Primary Completion Date
Oct 12, 2021Actual
Completion Date
Oct 12, 2021Actual
First Submitted Date
May 8, 2018
First Submission Date that Met QC Criteria
Jul 2, 2018
First Posted Date
Jul 3, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 7, 2022
Results First Submitted that Met QC Criteria
Nov 11, 2022
Results First Posted Date
Dec 12, 2022Actual
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 31, 2023
Last Update Posted Date
Aug 1, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GenmabINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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 purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors
Detailed Description
The trial is an open-label, multi-center first-in-human trial of GEN1029 (HexaBody®-DR5/DR5). The trial consists of two parts a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
Conditions Module
Conditions
Colorectal Cancer
Non-small Cell Lung Cancer
Triple Negative Breast Cancer
Renal Cell Carcinoma
Gastric Cancer
Pancreatic Cancer
Urothelial Cancer
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
48Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
GEN1029 (HexaBody®-DR5/DR5)
Experimental
Biological: GEN1029 (HexaBody®-DR5/DR5)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
GEN1029 (HexaBody®-DR5/DR5)
Biological
GEN1029 will be administered intravenously. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, >=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =<G1 within 24 hours, >=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any >=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).
From Day 1 to 28 days after the first dose of study drug
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically important']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.
Day 1 through Day 565 (corresponding to maximum observed duration)
Number of Participants With >= Grade 3 Laboratory Results
Number of participants with laboratory measurements of Grade >= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria (main):
Patients with advanced and/or metastatic cancer who have no available standard therapy or who are not candidates for available standard therapy, and for whom, in the opinion of the investigator, experimental therapy with GEN1029 may be beneficial.
Patient must be ≥ 18 years of age
Patients must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Have an acceptable hematological status
Have an acceptable renal function
Have an acceptable liver function
Have an Eastern Cooperative Oncology Group performance status of 0 or 1
Body weight ≥ 40kg
Patients both females and males, of childbearing or reproductive potential must agree to use adequate contraception from screening visit until six months after last infusion of GEN1029
Exclusion Criteria (main):
Acute deep vein thrombosis or clinically relevant pulmonary embolism, not stable for at least 8 weeks prior to first GEN1029 administration
Have clinically significant cardiac disease
Have uncontrolled hypertension as defined in the protocol
Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new (younger than 6 months) or progressive brain metastases or stroke
History of organ allograft (except for corneal transplant) or autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to the first dose of Investigational Medicinal Product (IMP)
Have received a cumulative dose of corticosteroid ≥ 150 mg prednisone (or equivalent doses of corticosteroids) within two weeks before the first GEN1029 administration
History of ≥ grade 3 allergic reactions to monoclonal antibody therapy as well as known or suspected allergy or intolerance to any agent given in the course of this trial
Radiotherapy within 14 days prior to first GEN1029 administration
Any prior therapy with a compound targeting DR4 or DR5
History of chronic liver disease or evidence of hepatic cirrhosis
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
Ruth Plummer, Professor
Newcastle Hospitals NHS Foundation Trust
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Yale University
New Haven
Connecticut
06510
United States
UT M.D Anderson Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
The sponsor decided to halt the development of GEN1029 due to a narrow therapeutic window after the dose-escalation part, hence the expansion part of the trial was not performed. Therefore, results are reported here only for the dose-escalation part.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
FG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 24, 2019
Sep 21, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
N/A
Intervention Model
Sequential 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
GEN1029 (HexaBody®-DR5/DR5)
Day 1 through Day 565 (corresponding to maximum observed duration)
The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
The CL of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.
From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.
From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to <10 mm of any pathological and non-pathological lymph nodes. The PR was defined as >=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Progression-Free Survival (PFS) According to RECIST 1.1
The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and >= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Overall Survival (OS) According to RECIST 1.1
Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Duration of Response (DoR) According to RECIST 1.1
The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Time to Response (TTR) According to RECIST 1.1
TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.
From Day 1 through 8.8 months (corresponding to maximum observed duration)
Houston
Texas
77030
United States
Hospital Univeritario Vall d'Hebron
Barcelona
Spain
START Madrid CIOCC
Madrid
Spain
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle
United Kingdom
The Royal Mardsen NHS Foundation Trust
Sutton
United Kingdom
FG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
FG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
FG004
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
FG005
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
FG006
Priming Regimen (GEN1029 0.1 mg/kg)
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
FG007
Intensified Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
FG00010 subjects
FG0017 subjects
FG0024 subjects
FG00311 subjects
FG0047 subjects
FG0057 subjects
FG0061 subjects
FG0071 subjects
COMPLETED
FG0001 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0009 subjects
FG0015 subjects
FG0024 subjects
FG00311 subjects
FG0047 subjects
FG0057 subjects
FG0061 subjects
FG0071 subjects
Type
Comment
Reasons
Investigator decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Death
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0035 subjects
FG004
New anti-cancer treatment
FG0005 subjects
FG0011 subjects
FG0022 subjects
FG0033 subjects
FG004
Unspecified reason
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Subject non-compliance
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
BG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
BG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
BG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
BG004
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
BG005
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
BG006
Priming Regimen (GEN1029 0.1 mg/kg)
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
BG007
Intensified Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG0017
BG0024
BG00311
BG0047
BG0057
BG0061
BG0071
BG00848
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, >=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =<G1 within 24 hours, >=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver function test results or amylase and/or lipase elevations; or any >=G3 possibly related non-hematological AE, which occurred during first 2 cycles (as specified in protocol).
The Dose-Determining Set (DDS) consists of all participants from the Safety Set (received at least one dose of GEN1029 and analyzed according to the actual trial treatment received) who either received between 80% and 125% of the planned dose and completed the DLT observation period (Days 1-28), or experienced a DLT during Cycle 1.
Posted
Count of Participants
Participants
From Day 1 to 28 days after the first dose of study drug
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
OG004
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
OG005
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
Units
Counts
Participants
OG00010
OG0016
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0020
OG003
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically important']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening during the treatment period including the safety follow-up period.
The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
Posted
Count of Participants
Participants
Day 1 through Day 565 (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
Primary
Number of Participants With >= Grade 3 Laboratory Results
Number of participants with laboratory measurements of Grade >= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.
The Safety Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual trial treatment received.
Posted
Count of Participants
Participants
Day 1 through Day 565 (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Secondary
Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05
The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.
Pharmacokinetic (PK) analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05
The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05
The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg*h/mL
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05
The CL of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05
The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05
The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
h
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
Secondary
Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05
The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Median
Full Range
h
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
1. Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
2. Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
3. Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
4. Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Plasma Concentration of Hx-DR5-01 and Hx-DR5-05
The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.
PK analysis set included all participants who were exposed to at least 1 dose of GEN1029 and who had at least 1 post-dose PK measurement. 'Number analyzed' denotes the number of participants evaluated for the specified time point.
Posted
Geometric Mean
Geometric Coefficient of Variation
µg/mL
Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029
From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.
The Immunogenicity Set consists of all participants who received at least one dose of GEN1029 and analyzed according to the actual treatment received and had at least one immunogenicity measurement taken.
Posted
Count of Participants
Participants
From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
Secondary
Change From Baseline in Anti-tumor Activity Measured by Tumor Shrinkage
Anti-tumor activity measured by tumor shrinkage was evaluated on based on of sum of the diameter(s) of all target lesions from the computerized tomography (CT) scan/positron emission tomography (PET)-CT scan. Largest tumor shrinkage is reported.
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual treatment received.
Posted
Mean
Standard Deviation
millimeter
From Baseline (Day 1) through 8.8 months (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Number of Participants With Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
The radiological evaluation was based on RECIST v1.1 using CT scan/PET-CT scan. The OR was defined as complete response (CR) or partial response (PR) per RECIST v1.1. The CR was defined as disappearance of all target and non-target lesions and reduction in short axis to <10 mm of any pathological and non-pathological lymph nodes. The PR was defined as >=30% decrease in sum of diameters of target lesions (compared to baseline), no unequivocal progression of existing non-target lesions, and no new lesion.
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Posted
Count of Participants
Participants
From Day 1 through 8.8 months (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Secondary
Progression-Free Survival (PFS) According to RECIST 1.1
The PFS was defined as the number of days from the date of first study drug administration to first progressive disease (PD) or death from any cause. The PD was defined as at least 20% (and >= 5 mm) increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum of the target LDs recorded while in trial or the appearance of 1 or more new lesions; unequivocal progression of existing non-target lesions; and/or new lesion. The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET scan. The PFS was estimated using Kaplan-Meier method.
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Posted
Median
95% Confidence Interval
months
From Day 1 through 8.8 months (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Secondary
Overall Survival (OS) According to RECIST 1.1
Overall survival was defined as the number of days from date of first study drug administration to death due to any cause. If a subject was not known to have died, then OS was censored, and the censoring date was the latest date the subject was known to be alive (on or before the cut-off date). The OS was estimated using Kaplan-Meier method.
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received.
Posted
Median
95% Confidence Interval
months
From Day 1 through 8.8 months (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Secondary
Duration of Response (DoR) According to RECIST 1.1
The radiological evaluation based on RECIST v1.1 was assessed using CT scan/PET-CT scan. The DoR was defined as duration from the first documentation of confirmed OR (CR or PR) to date of first progressive disease (PD) or death.
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
Posted
From Day 1 through 8.8 months (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Secondary
Time to Response (TTR) According to RECIST 1.1
TTR is defined as the number of days from first dose of study drug to the first documented confirmed CR or PR, which must be subsequently confirmed.
Full analysis set included all participants who received at least one dose of GEN1029 and were analyzed according to the actual trial treatment received. Participants who achieved confirmed OR by the investigator assessment were evaluated for this outcome measure.
Posted
From Day 1 through 8.8 months (corresponding to maximum observed duration)
ID
Title
Description
OG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
OG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
OG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
OG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Time Frame
For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Biweekly Regimen (GEN1029 0.1 mg/kg)
Participants received 0.1 mg/kg of GEN1029 every 2 weeks (Q2W) until the end of treatment.
3
10
3
10
8
10
EG001
Biweekly Regimen (GEN1029 0.2 mg/kg)
Participants received 0.2 mg/kg of GEN1029 Q2W until the end of treatment.
3
7
3
7
7
7
EG002
Biweekly Regimen (GEN1029 0.3 mg/kg)
Participants received 0.3 mg/kg of GEN1029 Q2W until the end of treatment.
1
4
2
4
4
4
EG003
Biweekly Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 Q2W until the end of treatment.
5
11
9
11
11
11
EG004
Biweekly Regimen (GEN1029 2.0 mg/kg)
Participants received 2.0 mg/kg of GEN1029 Q2W until the end of treatment.
4
7
6
7
7
7
EG005
Biweekly Regimen (GEN1029 3.0 mg/kg)
Participants received 3.0 mg/kg of GEN1029 Q2W until the end of treatment.
1
7
4
7
7
7
EG006
Priming Regimen (GEN1029 0.1 mg/kg)
Participants received a priming dose of 0.1 mg/kg of GEN1029 on Cycle 1 Day 1. After 14 days and thereafter once every 14 days, participants received full dose of 0.3 mg/kg until the end of treatment.
0
1
0
1
1
1
EG007
Intensified Regimen (GEN1029 1.0 mg/kg)
Participants received 1.0 mg/kg of GEN1029 once a week (Q1W) for the first 8 weeks then Q2W until the end of treatment.
1
1
1
1
1
1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Sinus Tachycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG0030 events0 affected11 at risk
EG0040 events0 affected7 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected1 at risk
EG0070 events0 affected1 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal Inflammation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Large Intestinal Obstruction
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hernia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Drug-Induced Liver Injury
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Jaundice Cholestatic
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Escherichia Urinary Tract Infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Peritonitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tinea Versicolour
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
International Normalised Ratio Increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Prothrombin Time Prolonged
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Malignant Neoplasm Progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lichenoid Keratosis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events2 affected7 at risk
EG0021 events1 affected4 at risk
EG0033 events3 affected11 at risk
EG0042 events2 affected7 at risk
EG0053 events1 affected7 at risk
EG0061 events1 affected1 at risk
EG0070 events0 affected1 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Diplopia
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Extraocular muscle paresis
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Eye pain
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Visual impairment
Eye disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Enteritis
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal oedema
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rectal tenesmus
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Asthenia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Chest discomfort
General disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Chest pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Drug withdrawal syndrome
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Early satiety
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Face oedema
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA (24.1)
Systematic Assessment
EG0004 events4 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Mucosal inflammation
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oedema
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain
General disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Biliary dilatation
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Cystitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oral herpes
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Rhinitis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Trichomoniasis
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 events3 affected10 at risk
EG0015 events3 affected7 at risk
EG0025 events2 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0005 events4 affected10 at risk
EG0016 events4 affected7 at risk
EG0025 events2 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
C-reactive protein increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Electrocardiogram T wave inversion
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Transaminases increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Weight decreased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Weight increased
Investigations
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0022 events1 affected4 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0002 events2 affected10 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Hypertrophic osteoarthropathy
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal discomfort
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Myopathy
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0003 events3 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nervousness
Psychiatric disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Bladder spasm
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pelvic pain
Reproductive system and breast disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0021 events1 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0011 events1 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Palmar-plantar erythrodysaesthesia syndrome
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Solar dermatitis
Skin and subcutaneous tissue disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hot flush
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0001 events1 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Spider vein
Vascular disorders
MedDRA (24.1)
Systematic Assessment
EG0000 events0 affected10 at risk
EG0010 events0 affected7 at risk
EG0020 events0 affected4 at risk
EG003
Results of the biweekly dosing regimens are based on the Clinical Study Report.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock).The sponsor cannot require changes to the communication and cannot extend the embargo.