Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/... | NCT03515551 | Trialant
NCT03515551
Sponsor
Immunocore Ltd
Status
Terminated
Last Update Posted
Mar 11, 2022Actual
Enrollment
29Actual
Phase
Phase 1Phase 2
Conditions
Select Advanced Solid Tumors
Interventions
IMCnyeso
Countries
United States
Canada
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03515551
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IMCnyeso-101
Secondary IDs
Not provided
Brief Title
Safety and Efficacy of IMCnyeso in Advanced NY-ESO-1 and/or LAGE-1A Positive Cancers
Official Title
A Phase I/II Study of IMCnyeso, HLA- A*0201-Restricted, NY-ESO-1- and LAGE-1A-specific Soluble T Cell Receptor and Anti-CD3 Bispecific Molecule, in HLA-A*0201 Positive Patients With Advanced NY-ESO-1 and/or LAGE - 1A Positive Cancer
Acronym
Not provided
Organization
Immunocore LtdINDUSTRY
Status Module
Record Verification Date
Mar 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic decision to stop development and not based on any safety concerns
Expanded Access Info
No
Start Date
Jun 15, 2018Actual
Primary Completion Date
May 10, 2021Actual
Completion Date
May 10, 2021Actual
First Submitted Date
Apr 5, 2018
First Submission Date that Met QC Criteria
May 2, 2018
First Posted Date
May 3, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 8, 2021
Results First Submitted that Met QC Criteria
Mar 9, 2022
Results First Posted Date
Mar 11, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 9, 2022
Last Update Posted Date
Mar 11, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Immunocore LtdINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
IMCnyeso is a bispecific fusion protein designed for the treatment of cancers that express NY-ESO-1 and/or LAGE-1A. This was a first-in-human trial designed to evaluate the safety and efficacy of IMCnyeso in HLA-A*02:01-positive adult participants whose cancer is positive for NY-ESO-1 and/or LAGE-A1.
Detailed Description
This was planned to be a multi-center, open label, dose finding Phase 1/2 study of single agent IMCnyeso administered in participants with NY-ESO-1 and/or LAGE-A1 positive tumors. The primary objective of the dose escalation phase (Phase 1) was to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of IMCnyeso in participants with advanced solid tumors. Preliminary efficacy was to be evaluated in Phase 2. The study was terminated early (prior to initiation of Phase 2) by the Sponsor as a strategic decision (not based on any safety signal).
Conditions Module
Conditions
Select Advanced Solid Tumors
Keywords
IMCnyeso
Immunotherapy
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
29Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Phase 1: Dose Escalation
Experimental
Four fixed-dose, dose escalation cohorts (Cohorts 1 to 4) and 3 intrapatient dose escalation cohorts (Cohorts 5 to 7) to establish the MTD/RP2D of IMCnyeso.
Drug: IMCnyeso
Phase 2: Dose Expansion
Experimental
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. Phase 2 was not initiated and data were not collected.
Drug: IMCnyeso
Interventions
Name
Type
Description
Arm Group Labels
Other Names
IMCnyeso
Drug
Weekly IV infusions of IMCnyeso
Phase 1: Dose Escalation
Phase 2: Dose Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1: Number of Participants With Dose-limiting Toxicities
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose
Up to 35 months
Phase 1: Number of Participants With Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Up to 35 months
Phase 1: Number of Participants With No Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Up to 35 months
Phase 2: Best Overall Response (BOR)
Best overall response per RECIST v.1.1
Up to 35 months
Secondary Outcomes
Measure
Description
Time Frame
Phase 2: Number of Participants With Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results.
Up to 35 months
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
HLA-A*0201 positive
NY-ESO-1 and/or LAGE-1A positive tumor
ECOG PS 0 or 1
Selected advanced solid tumors
Relapsed from, refractory to, or intolerant of standard therapy
If applicable, must agree to use highly effective contraception
Exclusion Criteria:
Symptomatic or untreated central nervous system metastasis
Inadequate washout from prior anticancer therapy
Significant ongoing toxicity from prior anticancer treatment
Impaired baseline organ function as evaluated by out-of-range laboratory values
Clinically significant cardiac disease
Active infection requiring systemic antibiotic therapy
Known history of human immunodeficiency virus (HIV)
Active hepatitis B virus (HBV) or hepatitis C virus (HCV)
Ongoing treatment with systemic steroids or other immunosuppressive therapies
Lopez JS, Milhem M, Butler MO, Thistlethwaite F, Van Tine BA, D'Angelo SP, Johnson ML, Sato T, Arkenau HT, Edukulla R, Wustner J, Marshall S, Rodon J. Phase 1 study of IMCnyeso, a T cell receptor bispecific ImmTAC targeting NY-ESO-1-expressing malignancies. Cell Rep Med. 2025 Apr 15;6(4):101994. doi: 10.1016/j.xcrm.2025.101994. Epub 2025 Mar 6.
See Also Links
Not provided
Available IPD Information
Not provided
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
There were a total of 28 unique participants; one participant from the 10 mcg cohort was sequentially enrolled in the 30-100 mcg cohort.
Recruitment Details
The sponsor elected to not proceed with the efficacy determining expansion phase (Phase 2) of IMCnyeso-101 for strategic reasons. Phase 2 data were not collected. As of 25 Mar 2021, further enrollment into the Phase 1 dose escalation phase was discontinued and last patient visit was 10 June 2021. Participants who were receiving study drug were allowed to continue treatment until unacceptable toxicity, disease progression, or other reason to discontinue occurred.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
FG001
Phase 1: IMCnyeso 10 mcg
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
Feb 24, 2020
Dec 1, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Phase 2: Number of Participants With No Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
Up to 35 months
Phase 1: Number of Participants With Best Overall Response (BOR)
Number of participants with best overall response, including complete response, partial response, stable disease, and progressive disease, based on local Investigator assessment as defined in RECIST v.1.1.
Up to 35 months
Phase 1 and Phase 2: Progression-free Survival
Progression-free survival is defined as the time from first dose until the date of objective progression, or death from any cause, whichever occurs first.
Up to 35 months
Phase 1 and Phase 2: Duration of Response
Duration of response is defined as the time from the date of first documented objective response (CR or PR) until the date of documented disease progression or death.
Up to 35 months
Phase 1 and Phase 2: Overall Survival
Overall Survival is defined as the time (in months) from the date of randomization to the date of death due to any cause.
Up to 35 months
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last)
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax)
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Time to Reach Maximum Plasma Concentration (Tmax)
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
Number of Participants With Anti-IMCnyeso Antibody Formation
Number of participants with positive treatment-boosted or treatment-induced anti-IMCnyeso antibody titers
Up to 35 months
Iowa City
Iowa
52242
United States
Washington University School of Medicine in St. Louis
St Louis
Missouri
63110
United States
Memorial Sloan Kettering Cancer Center
New York
New York
10065
United States
Thomas Jefferson University Hospital
Philadelphia
Pennsylvania
19107
United States
UPMC - Hillman Cancer Center
Pittsburgh
Pennsylvania
15232
United States
Tennessee Oncology NASH - SCRI
Nashville
Tennessee
37203
United States
MD Anderson Cancer Center
Houston
Texas
77030
United States
Princess Margaret Cancer Centre
Toronto
Ontario
M5G 2M9
Canada
Sarah Cannon Research Institute UK
London
W1G 6AD
United Kingdom
The Christie Hospital
Manchester
M20 4BX
United Kingdom
Royal Marsden Hospital
Sutton
SW3 6JJ
United Kingdom
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
FG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
FG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
FG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
FG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
FG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0033 subjects
FG0045 subjects1 participant from the 10 mcg cohort was sequentially enrolled in the 30-100 mcg cohort and is counted as starting in both columns; reason for study discontinuation recorded as part of 30-100 mcg cohort.
FG0054 subjects
FG0065 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0025 subjects
FG0033 subjects
FG0045 subjects
FG0054 subjects
FG0065 subjects
Type
Comment
Reasons
Death
FG0004 subjects
FG0011 subjects
FG0022 subjects
FG0032 subjects
FG0042 subjects
FG0054 subjects
FG0061 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Study ended by sponsor
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
FG004
Sequential enrollment in 30-100 mcg cohort
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
The Full Analysis Set includes all participants assigned to treatment who receive at least 1 full or partial dose of study drug; one participant that sequentially enrolled in two cohorts (10 mcg and 30-100 mcg) is represented in the 30-100 mcg cohort.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
BG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
BG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
BG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
BG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
BG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
BG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0012
BG0025
BG0033
BG0045
BG0054
BG0065
BG00728
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18-64 years old
Title
Measurements
BG0004
BG0012
BG0025
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Original cancer diagnosis
Count of Participants
Participants
Title
Denominators
Categories
Melanoma
Title
Measurements
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Phase 1: Number of Participants With Dose-limiting Toxicities
Dose-limiting toxicities were defined as an adverse event or abnormal laboratory value assessed as having a suspected relationship to study drug that occurs within the evaluation period, from the first dose up until Day 28 after the first dose
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.
Posted
Count of Participants
Participants
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Phase 1: Number of Participants With Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results. AE severity is graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.
Posted
Count of Participants
Participants
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
Primary
Phase 1: Number of Participants With No Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug.
Posted
Count of Participants
Participants
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Primary
Phase 2: Best Overall Response (BOR)
Best overall response per RECIST v.1.1
The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures.
Posted
Up to 35 months
ID
Title
Description
OG000
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
Units
Counts
Participants
OG0000
Secondary
Phase 2: Number of Participants With Adverse Events
Treatment-emergent adverse events are defined as any adverse event (AE) that started after the first dose of study drug up to 30 days after last dose of study drug, including abnormal laboratory values, vital signs, or electrocardiogram results.
The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures.
Posted
Up to 35 months
ID
Title
Description
OG000
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
Units
Counts
Participants
OG000
Secondary
Phase 2: Number of Participants With No Dose Interruptions or Reductions
Tolerability of study treatment was assessed by summarizing the number of participants with no treatment dose interruptions and dose reductions
The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for any Phase 2 outcome measures
Posted
Up to 35 months
ID
Title
Description
OG000
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
Units
Counts
Participants
OG000
Secondary
Phase 1: Number of Participants With Best Overall Response (BOR)
Number of participants with best overall response, including complete response, partial response, stable disease, and progressive disease, based on local Investigator assessment as defined in RECIST v.1.1.
The Full Analysis Set includes all participants assigned to treatment who receive at least 1 full or partial dose of study drug and for which evaluation was able to be made for at least 1 post-baseline tumor assessment.
Posted
Count of Participants
Participants
No
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Secondary
Phase 1 and Phase 2: Progression-free Survival
Progression-free survival is defined as the time from first dose until the date of objective progression, or death from any cause, whichever occurs first.
The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for this outcome measure in Phase 2.
Posted
Median
95% Confidence Interval
Months
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Secondary
Phase 1 and Phase 2: Duration of Response
Duration of response is defined as the time from the date of first documented objective response (CR or PR) until the date of documented disease progression or death.
The study was terminated during Phase 1 due to strategic reasons; analysis of duration of response was not able to be performed in Phase 1 because no complete or partial responses were observed and no data were collected for Phase 2.
Posted
Up to 35 months
ID
Title
Description
OG000
Phase 1: Dose Escalation
Four fixed-dose, dose escalation cohorts (Cohorts 1 to 4) and 3 intrapatient dose escalation cohorts (Cohorts 5 to 7) to establish the MTD/RP2D of IMCnyeso.
OG001
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
Units
Counts
Participants
OG000
Secondary
Phase 1 and Phase 2: Overall Survival
Overall Survival is defined as the time (in months) from the date of randomization to the date of death due to any cause.
The study was terminated during Phase 1 due to strategic reasons; data were not collected or analyzed for this outcome measure in Phase 2.
Posted
Median
95% Confidence Interval
Months
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
Secondary
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of Last Measurable Concentration (AUC0-last)
The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data.
Posted
Mean
Standard Deviation
hr*pg/mL
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
Secondary
Maximum Observed Plasma Drug Concentration After Single Dose Administration (Cmax)
The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data
Posted
Mean
Standard Deviation
pg/mL
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
Secondary
Time to Reach Maximum Plasma Concentration (Tmax)
The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data
Posted
Mean
Standard Deviation
Hours
Predose and 1, 2, 4, 6, 8, and 12 hours post dose on Cycle 1 Day 1 and Cycle 1 Day 15
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
Secondary
Number of Participants With Anti-IMCnyeso Antibody Formation
Number of participants with positive treatment-boosted or treatment-induced anti-IMCnyeso antibody titers
The pharmacokinetic analysis set includes participants in the safety analysis set with at least 1 post-dose sample providing evaluable data
Posted
Count of Participants
Participants
Up to 35 months
ID
Title
Description
OG000
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
Time Frame
Up to 35 months
Description
The Safety Analysis Set includes all participants who received at least 1 full or partial dose of study drug in Phase 1; the Phase 2 arm was not started and no data were collected. One participant was sequentially enrolled in two cohorts (10 mcg and 30-100 mcg). Events in either cohort are counted once in the total cohort.
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
Phase 1: IMCnyeso 3 mcg
Single-agent IMCnyeso at 3 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
4
4
3
4
4
4
EG001
Phase 1: IMCnyeso 10 mcg
Single-agent IMCnyeso at 10 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
1
3
1
3
3
3
EG002
Phase 1: IMCnyeso 30 mcg
Single-agent IMCnyeso at 30 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
2
5
1
5
5
5
EG003
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
2
3
1
3
3
3
EG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
2
5
2
5
5
5
EG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
4
4
3
4
4
4
EG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
1
5
3
5
5
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
Sinus tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Intra-abdominal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Lung infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Tracheal obstruction
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Muscular haemorrhage
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hypotension
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0007 events4 affected4 at risk
EG0016 events1 affected3 at risk
EG0028 events1 affected5 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0068 events2 affected5 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Ear discomfort
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Dry eye
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Eye pain
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0016 events2 affected3 at risk
EG0024 events2 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected4 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0012 events1 affected3 at risk
EG0022 events2 affected5 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 20.0
Systematic Assessment
EG0005 events2 affected4 at risk
EG0013 events2 affected3 at risk
EG00211 events4 affected5 at risk
EG003
Chills
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0025 events3 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events2 affected4 at risk
EG0013 events2 affected3 at risk
EG0022 events2 affected5 at risk
EG003
Oedema peripheral
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Axillary pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Face oedema
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Facial pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Feeling cold
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Influenza like illness
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Local swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Malaise
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Viral respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Corona virus infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Localised infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Skin infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Weight decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Oxygen saturation decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Body temperature increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Breath sounds abnormal
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Heart rate increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Weight increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0003 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0005 events2 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0014 events1 affected3 at risk
EG0022 events2 affected5 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0012 events1 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected5 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Muscle rigidity
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Muscle tightness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected5 at risk
EG003
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
Title
Denominators
Categories
Any treatment-emergent adverse event (TEAE)
Title
Measurements
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
Any TEAE Grade ≥3
Title
Measurements
OG0003
OG0011
OG0021
OG003
Any TEAE leading to death
Title
Measurements
OG0000
OG0010
OG0020
OG003
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
Title
Denominators
Categories
No dose interruption at any time
Title
Measurements
OG0002
OG0010
OG0020
OG0032
OG0042
OG0050
OG0060
No dose reduction at any time
Title
Measurements
OG0004
OG0013
OG0025
OG003
0
0
Phase 1: IMCnyeso 100 mcg
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
Title
Denominators
Categories
Complete Response
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Partial Response
Title
Measurements
OG0000
OG0010
OG0020
OG003
Stable Disease
Title
Measurements
OG0000
OG0010
OG0022
OG003
Progressive Disease
Title
Measurements
OG0003
OG0013
OG0023
OG003
Non-evaluable
Title
Measurements
OG0001
OG0010
OG0020
OG003
Single-agent IMCnyeso at 100 mcg dosed weekly intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using a fixed-dose regimen
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
OG007
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
Units
Counts
Participants
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
OG0070
Title
Denominators
Categories
Title
Measurements
OG0001.8(0.7 to 2.4)
OG0011.6(1.2 to 2.1)
OG0022.1(1.9 to 7.8)
OG0031.9(1.3 to 1.9)
OG0042.1(0.8 to 3.8)
OG0051.8(0.9 to 2.1)
OG0061.4(1.0 to NA)Not estimable due to insufficient number of events
0
OG0010
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
OG007
Phase 2: Dose Expansion
Three planned cohorts treated at the RP2D to make a preliminary assessment of the anti-tumor activity of IMCnyeso. The Phase 2 arm was not initiated.
Units
Counts
Participants
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
OG0070
Title
Denominators
Categories
Title
Measurements
OG0003.3(2.1 to 5.9)
OG001NA(2.2 to NA)Not estimable due to insufficient number of events
OG002NA(3.7 to NA)Not estimable due to insufficient number of events
OG0039.7(2.3 to NA)Not estimable due to insufficient number of events
OG004NA(5.2 to NA)Not estimable due to insufficient number of events
OG0057.5(0.9 to 11.7)
OG006NA(3.7 to NA)Not estimable due to insufficient number of events
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0045
OG0054
OG0064
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
Title
Measurements
OG00012500± 6910
OG00117700± 14400
OG002132000± 44600
OG003
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0045
OG0054
OG0064
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
Title
Measurements
OG0001130± 674
OG0011530± 1160
OG0026850± 1110
OG003
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0024
OG0033
OG0045
OG0054
OG0064
Title
Denominators
Categories
Cycle 1 Day 1
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0033
ParticipantsOG0043
ParticipantsOG0054
ParticipantsOG0064
Title
Measurements
OG0001.00± 0.00
OG0011.00± 0.00
OG0021.00± 0.00
OG003
Cycle 1 Day 15
ParticipantsOG0004
ParticipantsOG0013
ParticipantsOG0024
ParticipantsOG0032
OG004
Phase 1: IMCnyeso 30-100 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg starting on Cycle 1 Day 8)
OG005
Phase 1: IMCnyeso 30-100-180 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 180 mcg starting on Cycle 1 Day 15)
OG006
Phase 1: IMCnyeso 30-100-300 mcg
IMCnyeso administered intravenously on Days 1, 8, 15, and 22 of each 4-week cycle using an intrapatient escalation regimen (30 mcg on Cycle 1 Day 1, then 100 mcg on Cycle 1 Day 8, then 300 mcg starting on Cycle 1 Day 15)
Units
Counts
Participants
OG0004
OG0013
OG0025
OG0033
OG0045
OG0054
OG0065
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
OG0061
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0063 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0064 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
2 affected
3 at risk
EG0042 events1 affected5 at risk
EG0052 events2 affected4 at risk
EG0064 events2 affected5 at risk
1 events
1 affected
3 at risk
EG0044 events3 affected5 at risk
EG0052 events2 affected4 at risk
EG0064 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0062 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0043 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
7 events
3 affected
3 at risk
EG00410 events5 affected5 at risk
EG0058 events3 affected4 at risk
EG00616 events5 affected5 at risk
7 events
2 affected
3 at risk
EG0049 events2 affected5 at risk
EG00510 events3 affected4 at risk
EG00614 events3 affected5 at risk
4 events
2 affected
3 at risk
EG0040 events0 affected5 at risk
EG0054 events2 affected4 at risk
EG0064 events3 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
2 events
2 affected
3 at risk
EG0044 events2 affected5 at risk
EG0056 events3 affected4 at risk
EG00614 events5 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
2 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0066 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0055 events2 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0061 events1 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0063 events2 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0052 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0043 events1 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
2 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0051 events1 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0043 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0042 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
7 events
3 affected
3 at risk
EG0044 events2 affected5 at risk
EG0051 events1 affected4 at risk
EG0065 events4 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
3 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
1 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0065 events3 affected5 at risk
4 events
2 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
2 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0052 events1 affected4 at risk
EG0064 events2 affected5 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0061 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0041 events1 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0045 events1 affected5 at risk
EG0051 events1 affected4 at risk
EG0069 events3 affected5 at risk
1 events
1 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0062 events1 affected5 at risk
0 events
0 affected
3 at risk
EG0042 events2 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
0 events
0 affected
3 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected4 at risk
EG0060 events0 affected5 at risk
3
OG0043
OG0054
OG0064
0
OG0040
OG0050
OG0060
3
OG0044
OG0054
OG0063
0
OG0040
OG0050
OG0060
0
OG0042
OG0050
OG0061
3
OG0043
OG0053
OG0063
0
OG0040
OG0051
OG0061
295000
± 72400
OG004182000± 180000
OG00578800± 32500
OG006127000± 53700
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG0007270± 4530
OG00129500± 35900
OG002149000± 70500
OG003301000± 223000
OG004497000± 260000
OG005611000± 330000
OG006142000± NAInsufficient number of participants with evaluable data
16100
± 961
OG0046810± 5290
OG0053890± 932
OG0066710± 1380
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG0001090± 634
OG0011800± 1290
OG0026220± 1450
OG00317900± 1910
OG00419900± 3570
OG00526900± 3930
OG00665800± NAInsufficient number of participants with evaluable data
1.67
± 1.15
OG0041.00± 0.00
OG0051.25± 0.50
OG0061.00± 0.00
Participants
OG004
5
ParticipantsOG0054
ParticipantsOG0061
Title
Measurements
OG0001.00± 0.00
OG0011.00± 0.00
OG0021.00± 0.00
OG0031.00± 0.00
OG0041.00± 0.00
OG0051.00± 0.00
OG0062.00± NAInsufficient number of participants with evaluable data