Sarcoma Study of MORAb-004 Utilization: Research and Clin... | NCT01574716 | Trialant
NCT01574716
Sponsor
Morphotek
Status
Completed
Last Update Posted
Aug 21, 2019Actual
Enrollment
209Actual
Phase
Phase 2
Conditions
Metastatic Soft Tissue Sarcoma
Interventions
MORAb-004
Gemcitabine
Docetaxel
Gemcitabine
Docetaxel
Placebo
Countries
United States
Australia
Belgium
France
Italy
Netherlands
Protocol Section
Identification Module
NCT ID
NCT01574716
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MORAb-004-203-STS
Secondary IDs
ID
Type
Description
Link
2012-001399-12
EudraCT Number
Brief Title
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
Official Title
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel With MORAb-004 in Metastatic Soft Tissue Sarcoma
Acronym
SOURCE
Organization
MorphotekINDUSTRY
Status Module
Record Verification Date
Nov 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 7, 2012Actual
Primary Completion Date
Aug 11, 2015Actual
Completion Date
Aug 2, 2016Actual
First Submitted Date
Apr 4, 2012
First Submission Date that Met QC Criteria
Apr 9, 2012
First Posted Date
Apr 10, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 10, 2019
Results First Submitted that Met QC Criteria
Aug 1, 2019
Results First Posted Date
Aug 21, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 4, 2016
Certification/Extension First Submitted that Passed QC Review
Nov 29, 2016
Certification/Extension First Posted Date
Nov 30, 2016Estimated
Last Update Submitted Date
Aug 1, 2019
Last Update Posted Date
Aug 21, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MorphotekINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
Detailed Description
Not provided
Conditions Module
Conditions
Metastatic Soft Tissue Sarcoma
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
209Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MORAb-004, gemcitabine, docetaxel
Experimental
Drug: MORAb-004
Drug: Gemcitabine
Drug: Docetaxel
Placebo, gemcitabine, docetaxel
Active Comparator
Drug: Gemcitabine
Drug: Docetaxel
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MORAb-004
Drug
IV, Days 1 and 8 of every cycle until disease progression
MORAb-004, gemcitabine, docetaxel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 2: Radiologic Progression-free Survival (PFS)
PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
Secondary Outcomes
Measure
Description
Time Frame
Part 2: Symptomatic Progression-free Survival
PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.
From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age
Be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period
Have a histologically confirmed diagnosis of mSTS as defined by the 4 specified study subgrouped
Have been treated in the metastatic setting with 0 to 2 prior systemic regimens for mSTS (Systemic treatment regimens given in the neoadjuvant setting and maintenance therapies will not be considered as regimens in the metastatic setting for the purposes of this protocol. Prior anthracycline-based regimen is allowable but not required. Subjects with extra-skeletal small round blue cell sarcomas, including rhabdomyosarcomas, must have exhausted or be intolerant of standard first line anthracycline-based chemotherapy.)
Have measurable disease, as defined by RECIST v 1.1 assess within 2 weeks of study entry and have radiologically documented disease progression greater than or equal to a 10% increase in the sum of the longest diameters of target lesions present within 6 months prior to randomization
Have tumor tissue available for TEM-1 biomarker studies
Be willing and able to provide written informed consent
Exclusion Criteria:
Have received more than 2 prior systemic treatment regimens for mSTS
Have received either gemcitabine or docetaxel in any previous treatment for mSTS (regardless of the line of treatment)
Have a diagnosis of primary bone sarcoma of any histological type.
Have a history of clinically significant heart disease, or clinically significant arrhythmia on ECG within the past 6 months
Have a history of allergic reaction to prior monoclonal antibody or biologic agent
Have received previous treatment with MORAb-004 (anti-TEM-1)
Have a medical condition with a high risk of bleeding (e.g., a known bleeding disorder, a coagulopathy, or a tumor that involves the major vessels) or have a recent (within past 6 months) history of a significant bleeding event
Have undergone major surgical procedures or open biopsy, have significant traumatic injury within 30 days prior to the first date of study treatment, or have major surgical procedures anticipated during the study
Have a serious non-healing wound, an ulcer (including gastrointestinal), or a bone fracture
Jones RL, Chawla SP, Attia S, Schoffski P, Gelderblom H, Chmielowski B, Le Cesne A, Van Tine BA, Trent JC, Patel S, Wagner AJ, Chugh R, Heyburn JW, Weil SC, Wang W, Viele K, Maki RG. A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb-004) in metastatic soft-tissue sarcomas. Cancer. 2019 Jul 15;125(14):2445-2454. doi: 10.1002/cncr.32084. Epub 2019 Apr 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
In Part 1, a total of 16 participants were enrolled and treated in the study. A total of 225 participants were screened for entry into Part 2 of the study. Of these 225 participants, 46 were screen failures and 209 were randomized into the study, of which 207 participants were treated.
Recruitment Details
Participants took part in the study at 31 investigative sites in the United States, Australia, Italy, Netherlands, France and Belgium from 07 August 2012 to 02 August 2016.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 4 milligram per kilogram (mg/kg), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 milligram per square meter (mg/m^2), infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
IV, Days 1 and 8 of each cycle until disease progression
MORAb-004, gemcitabine, docetaxel
Docetaxel
Drug
IV, Day 8 of every cycle until disease progression
MORAb-004, gemcitabine, docetaxel
Gemcitabine
Drug
IV, Days 1 and 8 of each cycle until disease progression
Placebo, gemcitabine, docetaxel
Docetaxel
Drug
IV, Day 8 of every cycle until disease progression
Placebo, gemcitabine, docetaxel
Placebo
Drug
Placebo, gemcitabine, docetaxel
Part 2: Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
From date of first dose until date of death from any cause (up to approximately 3.5 years)
Part 2: Overall Response Rate (ORR)
ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
From date of first dose until disease progression (up to approximately 3.5 years)
Part 2: Radiologic Progression-free Survival Rate (PFR)
Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
Weeks 12, 24, 48 and 52
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
Up to approximately 3 years
Santa Monica
California
90404
United States
Mayo Clinic Jacksonville
Jacksonville
Florida
32224
United States
University of Miami
Miami
Florida
33136
United States
Moffitt Cancer Center
Tampa
Florida
33612
United States
Northwestern Memorial Hospital
Chicago
Illinois
60611
United States
Siouxland Hematology-Oncology
Sioux City
Iowa
51101
United States
Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore
Maryland
21231
United States
Dana-Farber Cancer Institute
Boston
Massachusetts
2215
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
Washington University
St Louis
Missouri
63110
United States
Mount Sinai Medical Center
New York
New York
10029
United States
Mayo Clinic - Rochester
Rochester
New York
55905
United States
The University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
27599
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Fox Chase Cancer Center
Philadelphia
Pennsylvania
19111
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City
Utah
84112
United States
Seattle Care Alliance
Seattle
Washington
United States
Canberra Hospital
Garran
Australian Capital Territory
2605
Australia
Royal North Shore Hospital
St Leonards
New South Wales
2065
Australia
Princess Alexandra Hospital
Woolloongabba
Queensland
4102
Australia
Ashford Cancer Centre Research
Kurralta Park
South Australia
5037
Australia
Sir Charles Gairdner Hospital
Perth
Western Australia
6009
Australia
UZ Leuven Medical Oncology
Leuven
3000
Belgium
Institut Gustave Roussy
Villejuif
94805
France
University of Claude Bernard
Villeurbanne
69100
France
Istituto Ortopedico Rizzoli
Bologna
40136
Italy
Leiden University Medical Center
Leiden
Netherlands
FG001
Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
FG002
Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
FG003
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
FG004
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9 percent [%] sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
FG0003 subjects
FG0014 subjects
FG0029 subjects
FG0030 subjects
FG0040 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG0003 subjects
FG0014 subjects
FG0029 subjects
FG0030 subjects
FG0040 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0011 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
Discontinuation of study by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003139 subjects
FG00470 subjects
Treated Participants
MORAb: 2 discontinued prior to treatment. Placebo: 3 randomized but received MORAb are in MORAb.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003137 subjects
FG004
Type
Comment
Reasons
Progressive disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 1: The intent-to-treat (ITT)/Safety population (SP) included all treated participants and was analyzed by treatment dose level. Part 2: The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the interactive randomization system (IxRS).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
BG001
Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
BG002
Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
BG003
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
BG004
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0014
BG0029
BG003139
BG00470
BG005225
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
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
White
Title
Measurements
BG0001
BG0013
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part 2: Radiologic Progression-free Survival (PFS)
PFS was defined as the time (in weeks) from the date of randomization to the date of first observation of disease progression according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or date of death, regardless of the cause.
The ITT population consisted of all randomized participants and were analyzed according to the treatment assigned by the IxRS.
Posted
Median
95% Confidence Interval
weeks
From date of first dose until date of first observation of disease progression, or death due to any cause (up to approximately 3 years)
ID
Title
Description
OG000
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
OG001
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Units
Counts
Participants
OG000139
OG00170
Title
Denominators
Categories
Title
Measurements
OG00018.7(11.6 to 27.4)
OG00124.1(11.1 to 36.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Two-sided log-rank test
= 0.6562
Hazard Ratio (HR)
1.08
2-Sided
95
0.77
1.50
Based on Cox PH model
Superiority
Secondary
Part 2: Symptomatic Progression-free Survival
PFS including symptomatic progression was defined as the time (in weeks) from the date of randomization to the date of the first observation of disease progression according to RECIST 1.1, symptomatic progression, or death due to any cause.
The ITT population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.
Posted
Median
95% Confidence Interval
weeks
From date of first dose until date of first observation of disease progression, symptomatic progression, or death due to any cause (up to approximately 3 years)
ID
Title
Description
OG000
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
OG001
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Secondary
Part 2: Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, regardless of the cause.
The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.
Posted
Median
95% Confidence Interval
months
From date of first dose until date of death from any cause (up to approximately 3.5 years)
ID
Title
Description
OG000
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
OG001
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Secondary
Part 2: Overall Response Rate (ORR)
ORR was defined as the percentage of subjects with either a complete response (CR) or a partial response (PR) based on RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters.
The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.
Posted
Number
percentage of participants
From date of first dose until disease progression (up to approximately 3.5 years)
ID
Title
Description
OG000
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
OG001
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Secondary
Part 2: Radiologic Progression-free Survival Rate (PFR)
Radiologic progression-free survival rate was defined as the percentage of subjects achieving radiologic PFS at the pre-specified time points.
The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.
Posted
Number
percentage of participants
Weeks 12, 24, 48 and 52
ID
Title
Description
OG000
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
OG001
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Secondary
Part 2: Number of Participants Who Had Relationship Between MORAb-004 Exposures and Biomarker Levels
The ITT Population consisted of all randomized participants and were analyzed according to treatment assigned by the IxRS.
Posted
Number
participants
Up to approximately 3 years
ID
Title
Description
OG000
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
OG001
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
Time Frame
From date of first dose until 45 days after last dose of study drug (approximately up to 4 years)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: MORAb-004 4.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 4 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
3
3
0
3
3
3
EG001
Part 1: MORAb-004 6.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 6 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
1
4
1
4
4
4
EG002
Part 1: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle until disease progression (approximately 28 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
8
9
6
9
9
9
EG003
Part 2: MORAb-004 8.0 mg/kg + Gemcitabine/Docetaxel
Participants received MORAb-004 8.0 mg/kg, infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). MORAb-004 was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
76
140
106
140
140
140
EG004
Part 2: Placebo + Gemcitabine/Docetaxel
Participants received normal saline (0.9% sodium chloride), infusion, intravenously on Days 1 and 8 in combination with gemcitabine 900 mg/m^2, infusion, intravenously on Days 1 and 8 and docetaxel 75 mg/m^2, infusion, intravenously on Day 8 of each 21-day treatment cycle for until disease progression (approximately 31 cycles). Normal saline (0.9% sodium chloride) was administered after the administration of gemcitabine on Day 1 and after the administration of gemcitabine/docetaxel on Day 8 in each 21-day treatment cycle.
35
67
45
67
66
67
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG0035 affected140 at risk
EG0044 affected67 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Haemolytic uraemic syndrome
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected9 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0023 affected9 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Atrial thrombosis
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Diastolic dysfunction
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Intussusception
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pancreatic cyst
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Chills
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Generalised oedema
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Infusion site extravasation
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Mucosal inflammation
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hepatotoxicity
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected9 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Enterocolitis infectious
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Influenza
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Liver abscess
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Lung infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Neutropenic sepsis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pneumocystis jiroveci infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pneumocystis jiroveci pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Pneumonia primary atypical
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Sepsis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Wound infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Platelet count decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Embolic stroke
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Encephalopathy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Memory impairment
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Transient global amnesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Haemothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pleural haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Capillary leak syndrome
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Vena cava thrombosis
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0028 affected9 at risk
EG00385 affected140 at risk
EG00437 affected67 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected3 at risk
EG0010 affected4 at risk
EG0028 affected9 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0024 affected9 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Lacrimation Increased
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0025 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0022 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0021 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Dry Mouth
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal Reflux Disease
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 14.1
Systematic Assessment
EG0003 affected3 at risk
EG0013 affected4 at risk
EG0026 affected9 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0022 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected3 at risk
EG0011 affected4 at risk
EG0024 affected9 at risk
EG003
Chills
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Influenza Like Illness
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Mucosal Inflammation
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Chest Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Infusion Related Reaction
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0023 affected9 at risk
EG003
Platelet Count Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Neutrophil Count Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
White Blood Cell Count Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Blood Creatinine Increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Blood Albumin Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Lymphocyte Count Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Weight Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Blood Calcium Decreased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0023 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0013 affected4 at risk
EG0021 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0021 affected9 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0013 affected4 at risk
EG0020 affected9 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal Chest Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0012 affected4 at risk
EG0023 affected9 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected9 at risk
EG003
Neuropathy Peripheral
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Peripheral Sensory Neuropathy
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Depression
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0022 affected9 at risk
EG003
Dyspnoea Exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Pleural Effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0002 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected9 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Rash Maculo-Papular
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Hot Flush
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Flushing
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Deafness Unilateral
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Dry Eye
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Vision Blurred
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Dental Caries
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Frequent Bowel Movements
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Peptic Ulcer
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Catheter Site Rash
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Early Satiety
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal Viral Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Lower Respiratory Tract Infection Viral
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Oral Candidiasis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Staphylococcal Skin Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0012 affected4 at risk
EG0020 affected9 at risk
EG003
Tooth Fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Increased Appetite
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Groin Pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Metatarsalgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Muscle Twitching
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Pain In Jaw
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Tumour Pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Loss Of Consciousness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Neuralgia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Urinary Tract Obstruction
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0020 affected9 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0022 affected9 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Oropharyngeal Discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Rhinitis Allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Nail Disorder
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0021 affected9 at risk
EG003
Rash Pruritic
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0010 affected4 at risk
EG0021 affected9 at risk
EG003
Skin Exfoliation
Skin and subcutaneous tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 affected3 at risk
EG0011 affected4 at risk
EG0020 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Eisai Medical Information
Eisai Inc.
1-888-274-2378
esi_oncmedinfo@eisai.com
ID
Term
D012509
Sarcoma
Ancestor Terms
ID
Term
D018204
Neoplasms, Connective and Soft Tissue
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000604563
ontuxizumab
D000093542
Gemcitabine
D000077143
Docetaxel
Ancestor Terms
ID
Term
D006571
Heterocyclic Compounds
D003841
Deoxycytidine
D003562
Cytidine
D011741
Pyrimidine Nucleosides
D011743
Pyrimidines
D006573
Heterocyclic Compounds, 1-Ring
D043823
Taxoids
D043822
Cyclodecanes
D003516
Cycloparaffins
D006840
Hydrocarbons, Alicyclic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D004224
Diterpenes
D013729
Terpenes
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
0 subjects
0 subjects
140 subjects
FG00467 subjects
0 subjects
70 subjects
1 subjects
FG0040 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00376 subjects
FG00435 subjects
Discontinuation of study by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00351 subjects
FG00431 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0035 subjects
FG0044 subjects
Brain metastases
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG0040 subjects
0
BG0040
BG0050
Between 18 and 65 years
BG0003
BG0013
BG0028
BG003103
BG00449
BG005166
>=65 years
BG0000
BG0011
BG0021
BG00336
BG00421
BG00559
3
BG00363
BG00432
BG005102
Male
BG0001
BG0012
BG0026
BG00376
BG00438
BG005123
2
BG00318
BG0048
BG00529
Not Hispanic or Latino
BG0002
BG0014
BG0027
BG003119
BG00461
BG005193
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0032
BG0041
BG0053
8
BG003116
BG00457
BG005185
Black or African American
Title
Measurements
BG0001
BG0011
BG0020
BG00312
BG0049
BG00523
Asian
Title
Measurements
BG0001
BG0010
BG0021
BG0037
BG0042
BG00511
Chinese
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0042
BG0052
American Indian or Alaskan Native
Title
Measurements
BG0000
BG0010
BG0020
BG0031
BG0040
BG0051
Other
Title
Measurements
BG0000
BG0010
BG0020
BG0033
BG0040
BG0053
Units
Counts
Participants
OG000139
OG00170
Title
Denominators
Categories
Title
Measurements
OG00018.1(11.3 to 24.0)
OG00124.0(10.7 to 36.1)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Two-sided log-rank test
=0.4469
Hazard Ratio (HR)
1.13
2-Sided
95
0.82
1.57
Based on Cox PH model
Superiority
Units
Counts
Participants
OG000139
OG00170
Title
Denominators
Categories
Title
Measurements
OG00018.3(16.2 to 21.1)
OG00121.1(14.2 to NA)The upper limit of confidence interval (CI), was not estimable since high number of participants were censored from analysis.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Log Rank
Two-sided log-rank test
0.3153
Hazard Ratio (HR)
1.23
2-Sided
95
0.82
1.83
Based on Cox PH model
Superiority
Units
Counts
Participants
OG000139
OG00170
Title
Denominators
Categories
Title
Measurements
OG00019.4
OG00120.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Difference equal to (=) (MORAb 8.0 mg/kg + Gemcitabine/Docetaxel) minus (Placebo + Gemcitabine/Docetaxel). Confidence interval based on a normal approximation to the binomial distribution.