JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-... | NCT02904226 | Trialant
NCT02904226
Sponsor
Jounce Therapeutics, Inc.
Status
Completed
Last Update Posted
Jul 3, 2023Actual
Enrollment
242Actual
Phase
Phase 1Phase 2
Conditions
Cancer
Interventions
JTX-2011
Nivolumab
Ipilimumab
Pembrolizumab
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02904226
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
JTX-2011-101
Secondary IDs
Not provided
Brief Title
JTX-2011 Alone and in Combination With Anti-PD-1 or Anti-CTLA-4 in Subjects With Advanced and/or Refractory Solid Tumors
Official Title
Phase 1/2 Multicenter Trial of ICOS Agonist Monoclonal Antibody (mAb) JTX-2011 Alone and in Combination With Nivolumab, Ipilimumab, or Pembrolizumab in Adult Subjects With Advanced and/or Refractory Solid Tumor Malignancies
Acronym
ICONIC
Organization
Jounce Therapeutics, Inc.INDUSTRY
Status Module
Record Verification Date
Jun 2023
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 2016Actual
Primary Completion Date
Jul 1, 2020Actual
Completion Date
Jul 1, 2020Actual
First Submitted Date
Sep 7, 2016
First Submission Date that Met QC Criteria
Sep 13, 2016
First Posted Date
Sep 16, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 2, 2021
Results First Submitted that Met QC Criteria
Sep 5, 2021
Results First Posted Date
Sep 9, 2021Actual
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
Jun 28, 2023
Last Update Posted Date
Jul 3, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Jounce Therapeutics, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
JTX-2011-101 is a Phase 1/2, open label, dose escalation and expansion clinical study of JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.
Detailed Description
JTX-2011 is an agonist monoclonal antibody that specifically binds to the Inducible CO-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, PK, PD, and preliminary efficacy of the ICOS agonist monoclonal antibody JTX-2011 alone and in combination with nivolumab, ipilimumab, or pembrolizumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent and the combination therapies, followed by an expansion phase in specified tumor types for single agent and the combination therapies.
Conditions Module
Conditions
Cancer
Keywords
ICOS
ICOS agonist monoclonal antibody
JTX-2011
Anti-PD-1
Nivolumab
ICONIC
Immunotherapy
Immuno-oncology
Cancer
Solid Tumor
Dose Escalation
Dose Expansion
Anti-CTLA-4
Ipilimumab
Pembrolizumab
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
242Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A (JTX-2011)
Experimental
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
Drug: JTX-2011
Part B (JTX-2011 + nivolumab)
Experimental
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
Drug: JTX-2011
Drug: Nivolumab
Part C (JTX-2011)
Experimental
Phase 2 expansion of JTX-2011 by IV infusion
Drug: JTX-2011
Part D (JTX-2011 + nivolumab)
Experimental
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
Drug: JTX-2011
Drug: Nivolumab
Part E (JTX-2011 + ipilimumab)
Experimental
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
Drug: JTX-2011
Drug: Ipilimumab
Part F (JTX-2011 + ipilimumab)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
JTX-2011
Drug
Specified dose on specified days
Part A (JTX-2011)
Part B (JTX-2011 + nivolumab)
Part C (JTX-2011)
Part D (JTX-2011 + nivolumab)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
46.3 months
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
46.3 months
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
46.3 months
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
46.3 months
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
46.3 months
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Must be willing and able to participate and comply with all trial requirements and able to provide signed and dated informed consent prior to initiation of any trial procedures
Evaluable or measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, and meet the requirements for the intended study cohort
Male or Female ≥ 18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Subjects with ECOG 2 may be considered for enrollment in Parts C, D, F, and H if approved by Medical Monitor
Have a predicted life expectancy of ≥ 3 months
Have laboratory values (obtained ≤ 28 days prior to first infusion day) in accordance with the study protocol
If medical history of the following, case should be reviewed by the Medical Monitor: prior biliary tract disorders (as based on Hepatobiliary SOC high level terms of: obstructive bile duct disorders, hepatic vascular disorders, structural and other bile duct disorders) or portal hypertension and/or hepatic vascular disorders
Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of each dose of JTX-2011
WOCBP and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
Exclusion Criteria:
Receiving concurrent anti-cancer treatment (excluding radiation therapy), either approved or investigational
Have refused standard therapy
Have received anti-cancer therapies listed below within the specified timeframe, or who have ongoing toxicity from prior therapy > Grade 1 according to the Common Terminology for Adverse Events (CTCAE). Exceptions to this are: > Grade 1 toxicities which in the opinion of the Investigator should not exclude the subject (e.g. alopecia, Grade 2 neuropathy, hypo- or hyperthyroidism or other endocrinopathies that are well-controlled with hormone replacement) and are approved by the Medical Monitor.
Have received biologic therapy, including immunotherapy, < 28 days prior to C1D1;
Have received CAR-T therapy;
Have received chemotherapy < 21 days prior to C1D1, or < 42 days for mitomycin or nitrosoureas;
Have received targeted small molecule therapy < 14 days prior to C1D1;
Have undergone organ transplantation including allogeneic or autologous stem-cell transplantation, at any time;
Have undergone a major surgery (excluding minor procedures, e.g. placement of vascular access, biopsy, etc.) < 6 months prior to the first day of study treatment, C1D1
Have a history of intolerance, hypersensitivity, or treatment discontinuation due to severe immune adverse events on prior immunotherapy, or documented presence of neutralizing anti-drug antibody to nivolumab, ipilimumab, or pembrolizumab. Subjects who discontinued prior immunotherapies for immune-related adverse events that are well-controlled with appropriate treatment may be enrolled if approved by the Medical Monitor.
Have a diagnosis of immunodeficiency, either primary or acquired, or treatment with systemic steroids or any other form of immunosuppressive therapy within 7 days prior to C1D1. Exception: inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease as well as a one-time dose of immunosuppressive agents used prophylactically for contrast allergies
Have any active disease requiring systemic immunosuppressive treatment
Have known severe intolerance to or life-threatening hypersensitivity reactions to humanized monoclonal antibodies or intravenous immunoglobulin preparations; any history of anaphylaxis; prior history of human anti-human antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent
Are symptomatic or have uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation (brain metastases that are stable and asymptomatic, either treated or untreated, will be allowed)
Have current second malignancy at other sites, which requires treatment, or in the judgement of the Investigator, may require treatment within the next year. Concurrent malignancies that do not require treatment and are clinically stable are allowed. A past history of other malignancies is allowed as long as the subject is not receiving specific treatment other than hormonal therapy, and, in the judgement of the Investigator, is unlikely to have a recurrence.
Have active and clinically relevant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or human immunodeficiency virus (HIV) (testing not required)
Have received live vaccines within past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date prior to first infusion day)
Women who are pregnant or breastfeeding
Have experienced symptomatic cardiac disease that is unresponsive to surgical or medical management
Have any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical trial data interpretation
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
Stew Kroll
Jounce Therapeutics, Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Stanford University School of Medicine
Palo Alto
California
94304
United States
Sarah Cannon Research Institute at HealthONE
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The protocol enrollment number of 242 is the number of participants who signed the ICF. The number that Started the Participant flow module (218) are those subjects who received any amount of study drug (JTX-2011 and/or nivolumab and/or ipilimumab and/or pembrolizumab). The difference between these two values (24) are the number of patients who screen failed.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
FG001
Part B (JTX-2011 + Nivolumab)
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
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 30, 2019
Jun 2, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
Drug: JTX-2011
Drug: Ipilimumab
Part G (JTX-2011 + pembrolizumab)
Experimental
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
Drug: JTX-2011
Drug: Pembrolizumab
Part H (JTX-2011 + pembrolizumab)
Experimental
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
Drug: JTX-2011
Drug: Pembrolizumab
Part E (JTX-2011 + ipilimumab)
Part F (JTX-2011 + ipilimumab)
Part G (JTX-2011 + pembrolizumab)
Part H (JTX-2011 + pembrolizumab)
ICOS agonist monoclonal antibody
Nivolumab
Drug
Specified dose on specified days
Part B (JTX-2011 + nivolumab)
Part D (JTX-2011 + nivolumab)
Opdivo
Ipilimumab
Drug
Specified dose on specified days
Part E (JTX-2011 + ipilimumab)
Part F (JTX-2011 + ipilimumab)
Yervoy
Pembrolizumab
Drug
Specified dose on specified days
Part G (JTX-2011 + pembrolizumab)
Part H (JTX-2011 + pembrolizumab)
Keytruda
Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
46.3 months
Number of Participants With Dose Limiting Toxicities
Number of participants with at least one dose limiting toxicity (DLT)
33 months
Overall Response Rate
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
46.5 months
Disease Control Rate
Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
46.5 months
Progression Free Survival
Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
46.5 months
6 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
46.5 months
12 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
46.5 months
Landmark Overall Survival at 6 Months
Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
46.5 months
Landmark Overall Survival at 12 Months
Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
46.5 months
Overall Survival
The time from first dose date to the date of death for any cause
46.5 months
Denver
Colorado
80218
United States
Yale New Haven Hospital
New Haven
Connecticut
06510
United States
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C.
District of Columbia
20007
United States
The University of Chicago Medicine Comprehensive Cancer Center
Chicago
Illinois
60637
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Beth Israel Deaconess Medical Center
Boston
Massachusetts
02215
United States
Dana Farber Cancer Institute
Boston
Massachusetts
02215
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Memorial Sloan Kettering Monmouth
Middletown
New Jersey
07748
United States
Memorial Sloan Kettering Westchester
Harrison
New York
10604
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Sarah Cannon Research Institute at TriStar Health
Nashville
Tennessee
37203
United States
The University of Texas - MD Anderson Cancer Center
Houston
Texas
77030
United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio
Texas
78229
United States
University of Washington
Seattle
Washington
98109
United States
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
FG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
FG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
FG004
Part E (JTX-2011 + Ipilimumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
FG005
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion JTX-2011: Specified dose on specified days Ipilimumab: Specified dose on specified days
FG006
Part G (JTX-2011 + Pembrolizumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
FG007
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion JTX-2011: Specified dose on specified days Pembrolizumab: Specified dose on specified days
FG00040 subjects
FG00131 subjects
FG00230 subjects
FG003100 subjects
FG00411 subjects
FG0050 subjects
FG0066 subjects
FG0070 subjects
COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0034 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG00040 subjects
FG00129 subjects
FG00230 subjects
FG00396 subjects
FG00411 subjects
FG0050 subjects
FG0066 subjects
FG0070 subjects
Parts F and H were never opened as clinical and translational data from ICONIC suggests that alternative regimens may be preferable to those proposed in Parts F and H.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
BG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
BG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
BG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
BG004
Part E (JTX-2011 + Ipilimumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
BG005
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
BG006
Part G (JTX-2011 + Pembrolizumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
BG007
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00040
BG00131
BG00230
BG003100
BG00411
BG0050
BG0066
BG0070
BG008218
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
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.6± 10.94
BG00156.2± 9.87
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00022
BG00119
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0004
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00040
BG00131
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 Treatment Emergent Adverse Events (TEAE)
Number of participants with an adverse event occurring from the time of informed consent until resolution or new therapy initiated or for 28 days post final dose if no new therapy is initiated
Posted
Count of Participants
Participants
46.3 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG004
Part E (JTX-2011 + Ipilimumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
OG005
Part G (JTX-2011 + Pembrolizumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
Units
Counts
Participants
OG00040
OG00131
OG00230
OG003
Title
Denominators
Categories
Title
Measurements
OG00038
OG00131
OG00230
OG003
Primary
Number of Participants With Grade 5 (Fatal) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 5 (fatal) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Posted
Count of Participants
Participants
46.3 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Number of Participants With Grade 4 (Life Threatening) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 4 (life threatening) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Posted
Count of Participants
Participants
46.3 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Number of Participants With Grade 3 (Sever) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 3 (severe) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03."
Posted
Count of Participants
Participants
46.3 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Number of Participants With Grade 2 (Moderate) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 2 (moderate) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Posted
Count of Participants
Participants
46.3 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Number of Participants With Grade 1 (Mild) Treatment Emergent Adverse Events (TEAE)
Number of participants with Grade 1 (mild) treatment emergent adverse events (TEAE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
Posted
Count of Participants
Participants
46.3 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Number of Participants With Dose Limiting Toxicities
Number of participants with at least one dose limiting toxicity (DLT)
Part C and D did not have any participants analyzed for this outcome measure because DLT is only relevant to the Phase 1 parts of study (Part A, Part B, Part E and Part G).
Posted
Count of Participants
Participants
33 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Overall Response Rate
Overall response rate (ORR) is defined as the proportion of subjects with a Best Overall Response characterized as either a Complete Response (CR) or Partial Response (PR) as defined by RECISTv1.1 guidelines based on investigator's review
Response Evaluable Set: subjects who received any study drug and have a baseline tumor assessment, and either has at least one post-baseline tumor assessment scan and/or discontinued treatment due to death or disease progression The number of participants analyzed is zero for Part F and Part H because there were no participants enrolled in those two groups of the study
Posted
Count of Participants
Participants
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
Primary
Disease Control Rate
Disease Control Rate: Percent Subjects with confirmed Complete Response + confirmed Partial Response + BoR of SD (or unconfirmed complete response or partial response lasting at least 53 days from the date of first dose)
Posted
Count of Participants
Participants
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
Progression Free Survival
Progression free survival, as determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Posted
Median
95% Confidence Interval
months
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
Primary
6 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 6 months, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
The 95% CI is not estimable by Kaplan-Meier method for Part E since the probability of event was 0.
Posted
Mean
95% Confidence Interval
Probability of event free at month 6 (%)
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Primary
12 Month Landmark Progression Free Survival
Percentage of patients that are progression free at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Posted
Mean
95% Confidence Interval
Probability of event free at month 12(%)
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Primary
Landmark Overall Survival at 6 Months
Percentage of patients that are alive at 6 month, estimated by the Kaplan Meier method as the probability of being event-free at 6 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Posted
Mean
95% Confidence Interval
Probability of event free at month 6 (%)
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Primary
Landmark Overall Survival at 12 Months
Percentage of patients that are alive at 12 month, estimated by the Kaplan Meier method as the probability of being event-free at 12 months out of the entire 45.5-month primary study period. This method generates survival probability estimates across the Time Frame of the study using all data throughout the course of the trial.
Posted
Mean
95% Confidence Interval
Probability of event free at month 12(%)
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Primary
Overall Survival
The time from first dose date to the date of death for any cause
Posted
Median
95% Confidence Interval
months
46.5 months
ID
Title
Description
OG000
Part A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
OG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
OG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
OG004
Time Frame
Participants could be monitored for up to 46.5 months (the time from signing consent to 28 days after the last dose is administered)
Description
The first patient signed informed consent on 2016-08-17; 28 days after the last dose was 2020-07-01, therefore AE reporting took place over the course of 46.5 months. AE data was collected via adverse event case report forms using log forms. The number of participants at risk for Serious AEs, All-Cause Mortality, and Other (Not Including Serious) AEs is zero for Part F and Part H because no subjects were enrolled in these parts of the study.
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 A (JTX-2011)
Phase 1 dose escalation and expansion of JTX-2011 by intravenous (IV) infusion
JTX-2011: Specified dose on specified days
19
40
14
40
38
40
EG001
Part B (JTX-2011 + Nivolumab)
Phase 1 dose escalation and expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
19
31
9
31
31
31
EG002
Part C (JTX-2011)
Phase 2 expansion of JTX-2011 by IV infusion
JTX-2011: Specified dose on specified days
22
30
16
30
30
30
EG003
Part D (JTX-2011 + Nivolumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with nivolumab by IV infusion
JTX-2011: Specified dose on specified days
Nivolumab: Specified dose on specified days
68
100
38
100
98
100
EG004
Part E (JTX-2011 + Ipilimumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
6
11
6
11
11
11
EG005
Part F (JTX-2011 + Ipilimumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with ipilimumab by IV infusion
JTX-2011: Specified dose on specified days
Ipilimumab: Specified dose on specified days
0
0
0
0
0
0
EG006
Part G (JTX-2011 + Pembrolizumab)
Phase 1 dose escalation of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
5
6
2
6
6
6
EG007
Part H (JTX-2011 + Pembrolizumab)
Phase 2 expansion of JTX-2011 by IV infusion in combination with pembrolizumab by IV infusion
JTX-2011: Specified dose on specified days
Pembrolizumab: Specified dose on specified days
0
0
0
0
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Pericarditis
Cardiac disorders
MedDRA
Systematic Assessment
Pericarditis
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG0031 affected100 at risk
EG004
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Upper gastrointestinal hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Colitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Duodenal stenosis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Haematemesis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Ileus
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Obstruction gastric
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Pancreatitis
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Cellulitis
Infections and infestations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Peritonitis
Infections and infestations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Abdominal infection
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Bacteraemia
Infections and infestations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pelvic abscess
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Peritonitis bacterial
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Sialoadenitis
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Bronchial obstruction
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Paraneoplastic pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pharyngeal inflammation
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Chondrosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Malignant pleural effusion
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Tumor associated fever
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Tumor hemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Tumor pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Chest discomfort
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Sudden death
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Hypercalcaemia
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Thrombotic microangiopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Cervical spinal stenosis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Pericardial effusion
Cardiac disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Bile duct obstruction
Hepatobiliary disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Jaundice
Hepatobiliary disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Encephalopathy
Nervous system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Mental status changes
Psychiatric disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Spinal fusion surgery
Surgical and medical procedures
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
Intermittent nausea
EG00010 affected40 at risk
EG00114 affected31 at risk
EG0028 affected30 at risk
EG00332 affected100 at risk
EG004
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0004 affected40 at risk
EG0018 affected31 at risk
EG0027 affected30 at risk
EG003
Diarrhea
Gastrointestinal disorders
Systematic Assessment
EG0007 affected40 at risk
EG0014 affected31 at risk
EG0025 affected30 at risk
EG003
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0003 affected40 at risk
EG0018 affected31 at risk
EG0026 affected30 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0008 affected40 at risk
EG0012 affected31 at risk
EG0028 affected30 at risk
EG003
Dysphagia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0022 affected30 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected31 at risk
EG0023 affected30 at risk
EG003
Ascites
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0022 affected30 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Dry mouth
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Dyspepsia
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected31 at risk
EG0021 affected30 at risk
EG003
Proctalgia
Gastrointestinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Flatulence
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0022 affected30 at risk
EG003
Retching
Gastrointestinal disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Rectal hemorrhage
Gastrointestinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0009 affected40 at risk
EG00110 affected31 at risk
EG00215 affected30 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0006 affected40 at risk
EG0015 affected31 at risk
EG0024 affected30 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0006 affected40 at risk
EG0013 affected31 at risk
EG0021 affected30 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0002 affected40 at risk
EG0013 affected31 at risk
EG0026 affected30 at risk
EG003
Non-cardiac chest pain
General disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Chest discomfort
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected31 at risk
EG0020 affected30 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Peripheral swelling
General disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0008 affected40 at risk
EG0015 affected31 at risk
EG00210 affected30 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected40 at risk
EG0013 affected31 at risk
EG0025 affected30 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0004 affected40 at risk
EG0014 affected31 at risk
EG0022 affected30 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected31 at risk
EG0023 affected30 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected31 at risk
EG0026 affected30 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected31 at risk
EG0023 affected30 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected31 at risk
EG0021 affected30 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0005 affected40 at risk
EG0013 affected31 at risk
EG0026 affected30 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0004 affected40 at risk
EG0016 affected31 at risk
EG0023 affected30 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0003 affected40 at risk
EG0013 affected31 at risk
EG0022 affected30 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0004 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected31 at risk
EG0023 affected30 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected40 at risk
EG0015 affected31 at risk
EG0022 affected30 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected40 at risk
EG0013 affected31 at risk
EG0021 affected30 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected31 at risk
EG0020 affected30 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected31 at risk
EG0022 affected30 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected31 at risk
EG0020 affected30 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Aspartate aminotransferase increased
Investigations
Systematic Assessment
EG0005 affected40 at risk
EG0013 affected31 at risk
EG0024 affected30 at risk
EG003
Weight decreased
Investigations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0025 affected30 at risk
EG003
Alanine aminotransferase increased
Investigations
Systematic Assessment
EG0005 affected40 at risk
EG0012 affected31 at risk
EG0024 affected30 at risk
EG003
Blood alkaline phosphatase increased
Investigations
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected31 at risk
EG0023 affected30 at risk
EG003
Blood bilirubin increased
Investigations
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected31 at risk
EG0022 affected30 at risk
EG003
Blood creatinine increased
Investigations
Systematic Assessment
EG0001 affected40 at risk
EG0013 affected31 at risk
EG0021 affected30 at risk
EG003
Lymphocyte count decreased
Investigations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Electrocardiogram QT prolonged
Investigations
Systematic Assessment
EG0003 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
White blood cell count decreased
Investigations
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Blood phosphorus decreased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
International normalised ratio increased
Investigations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0004 affected40 at risk
EG0010 affected31 at risk
EG0028 affected30 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0004 affected40 at risk
EG0012 affected31 at risk
EG0021 affected30 at risk
EG003
Neuropathy peripheral
Nervous system disorders
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected31 at risk
EG0020 affected30 at risk
EG003
Hypoaesthesia
Nervous system disorders
Systematic Assessment
EG0001 affected40 at risk
EG0012 affected31 at risk
EG0021 affected30 at risk
EG003
Balance disorder
Nervous system disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0001 affected40 at risk
EG0013 affected31 at risk
EG0022 affected30 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0005 affected40 at risk
EG0012 affected31 at risk
EG0022 affected30 at risk
EG003
Oral candidiasis
Infections and infestations
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0001 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Skin infection
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Furuncle
Infections and infestations
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected40 at risk
EG0014 affected31 at risk
EG0023 affected30 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0005 affected40 at risk
EG0011 affected31 at risk
EG0022 affected30 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 affected40 at risk
EG0013 affected31 at risk
EG0020 affected30 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0003 affected40 at risk
EG0019 affected31 at risk
EG0023 affected30 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0009 affected40 at risk
EG0014 affected31 at risk
EG0027 affected30 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Anxiety
Psychiatric disorders
Systematic Assessment
EG0002 affected40 at risk
EG0012 affected31 at risk
EG0021 affected30 at risk
EG003
Confusional state
Psychiatric disorders
Systematic Assessment
EG0002 affected40 at risk
EG0010 affected31 at risk
EG0021 affected30 at risk
EG003
Sleep disorder
Psychiatric disorders
Systematic Assessment
EG0000 affected40 at risk
EG0011 affected31 at risk
EG0020 affected30 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0003 affected40 at risk
EG0011 affected31 at risk
EG0022 affected30 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0002 affected40 at risk
EG0011 affected31 at risk
EG0021 affected30 at risk
EG003
Hot flush
Vascular disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0022 affected30 at risk
EG003
Haematuria
Renal and urinary disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected31 at risk
EG0020 affected30 at risk
EG003
Renal failure
Renal and urinary disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0003 affected40 at risk
EG0012 affected31 at risk
EG0022 affected30 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected40 at risk
EG0012 affected31 at risk
EG0020 affected30 at risk
EG003
Hyerthyroidism
Endocrine disorders
Systematic Assessment
EG0000 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 at risk
EG003
Portal vein thrombosis
Hepatobiliary disorders
Systematic Assessment
EG0001 affected40 at risk
EG0010 affected31 at risk
EG0020 affected30 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
Any publication ("pub.") can be restricted until the 1st to occur of (a) pub. of the clinical trial results, or (b) 18 mo's after the Primary Completion Date. Pub. rights depend on PI conducting the study in compliance with the Protocol, that the pub. is made in a recognized journal or conference, and makes use of all study data. The Sponsor can require removal of Sponsor's confidential information from any pub. and can defer pub. for up to an add'l 60 days to file a related patent application.