A Study of Epacadostat (INCB024360) in Combination With D... | NCT02318277 | Trialant
NCT02318277
Sponsor
Incyte Corporation
Status
Completed
Last Update Posted
Jan 13, 2022Actual
Enrollment
176Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors
Head and Neck Cancer
Lung Cancer
UC (Urothelial Cancer)
Interventions
MEDI4736
INCB024360
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02318277
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 24360-203 / ECHO-203
Secondary IDs
Not provided
Brief Title
A Study of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Official Title
A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Epacadostat (INCB024360) in Combination With Durvalumab (MEDI4736) in Subjects With Selected Advanced Solid Tumors (ECHO-203)
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Jan 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 5, 2015Actual
Primary Completion Date
Aug 28, 2019Actual
Completion Date
Oct 16, 2020Actual
First Submitted Date
Nov 19, 2014
First Submission Date that Met QC Criteria
Dec 12, 2014
First Posted Date
Dec 17, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 28, 2020
Results First Submitted that Met QC Criteria
Dec 2, 2020
Results First Posted Date
Dec 29, 2020Actual
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
Jan 7, 2022
Last Update Posted Date
Jan 13, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Name
Class
AstraZeneca
INDUSTRY
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
The purpose of this study is to explore the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of INCB024360 administered in combination with MEDI4736 in subjects with selected advanced solid tumors.
Detailed Description
Not provided
Conditions Module
Conditions
Solid Tumors
Head and Neck Cancer
Lung Cancer
UC (Urothelial Cancer)
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
176Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
MEDI4736 + INCB024360
Experimental
MEDI4736 at selected dose levels every 2 weeks + INCB024360 25 mg BID as starting dose, followed by dose escalations until MTD or PAD is identified
Drug: MEDI4736
Drug: INCB024360
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MEDI4736
Drug
MEDI4736 administered intravenously (IV) every two weeks (q2w)
MEDI4736 + INCB024360
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Phase 1 : Number of Treatment-Emergent Adverse Events (TEAE)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured every 8 weeks for duration of study treatment [approximately 12 months]
Secondary Outcomes
Measure
Description
Time Frame
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured every 8 weeks for duration of study treatment [approximately 6 months]
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, age 18 years or older
Histologically or cytologically confirmed diagnosis of selected locally advanced or metastatic solid tumors
Must have failed at least 1 prior treatment regimen for locally advanced or metastatic disease or be intolerant to treatment or refuse standard treatment
Exclusion Criteria:
Laboratory and medical history parameters not within protocol-defined range
Participation in any other study in which receipt of an investigational study drug occurred within 28 days or 5 half-lives (whichever is longer) prior to first dose
Prior treatment with immune checkpoint inhibitors (eg, anti-CTLA-4, anti-PD-1, anti-PD-L1, and any other antibody or drug specifically targeting T-cell co-stimulation) or an IDO inhibitor (exception is tumor types in which a PD-1 pathway targeted agent is approved, e.g. melanoma, non-small cell lung cancer.)
Receipt of any anticancer medication in the 21 days prior to receiving the first dose of study medication
Has an active or inactive autoimmune process
Evidence of interstitial lung disease or active, non-infectious pneumonitis
Prior radiotherapy within 2 weeks of initiating treatment; Must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Untreated central nervous system (CNS) metastases or CNS metastases that have progressed
Naing A, Algazi AP, Falchook GS, Creelan BC, Powderly J, Rosen S, Barve M, Mettu NB, Triozzi PL, Hamm J, Zhou G, Walker C, Dong Z, Patel MR. Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors. Cancer. 2023 Jan 1;129(1):71-81. doi: 10.1002/cncr.34512. Epub 2022 Oct 30.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 235 participants were screened and 59 participants were screen failures. A total of 176 participants ( 34 participants in Phase 1 and 142 in Phase 2) were enrolled in the study. Study enrollment was permanently discontinued on 24 Apr 2018 as a strategic decision. At the time of data cut-off, 28 Aug 2019, 1 participant was ongoing.
Recruitment Details
This study was conducted at 13 study sites in the United States. Participants were enrolled at 12 study sites.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
FG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
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
Sep 21, 2018
Aug 27, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Italy
Spain
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
INCB024360
Drug
INCB024360: Oral daily dosing
MEDI4736 + INCB024360
Phase 2: Number of Treatment-Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].
Denver
Colorado
United States
Miami
Florida
United States
Port Saint Lucie
Florida
United States
Sarasota
Florida
United States
Tampa
Florida
United States
Chicago
Illinois
United States
Louisville
Kentucky
United States
Durham
North Carolina
United States
Huntersville
North Carolina
United States
Winston-Salem
North Carolina
United States
Dallas
Texas
United States
Houston
Texas
United States
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
FG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
FG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
FG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
FG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
FG006
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
FG007
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0048 subjects
FG0059 subjects
FG00649 subjects
FG00793 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
NOT COMPLETED
FG0006 subjects
FG0013 subjects
FG0024 subjects
FG0034 subjects
FG0048 subjects
FG0059 subjects
FG00649 subjects
FG00793 subjects
Type
Comment
Reasons
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Participant trial terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0005 subjects
FG0013 subjects
FG0021 subjects
FG0034 subjects
FG004
Transitioned to Hospice
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Intent-to-Treat Population who are enrolled in Phase 1 and 2 part of the study
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
BG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
BG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
BG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
BG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
BG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
BG006
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
BG007
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0013
BG0024
BG0034
BG0048
BG0059
BG00649
BG00793
BG008176
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00070.8± 4.79
BG00175.7± 7.23
BG00265.3± 9.07
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0012
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG0006
BG0013
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
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 Treatment-Emergent Adverse Events (TEAE)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
The Phase 1 safety population includes all subjects enrolled in the Phase 1 portion of the study who received at least 1 dose of INCB024360 or MEDI4736. Treatment groups were determined according to the actual treatment the subject received on Day 1 regardless of the actual study drug the subject received during participation in the study.
Posted
Count of Participants
Participants
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Units
Counts
Participants
OG0006
OG0013
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0006
OG0013
OG0024
OG003
Primary
Phase 2: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Intent-to-Treat Population : All subjects who are enrolled in the Phase 2 portion of the study.
Posted
Count of Participants
Participants
Measured every 8 weeks for duration of study treatment [approximately 12 months]
ID
Title
Description
OG000
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG001
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Secondary
Phase 1: Objective Response Rate (ORR) as Determined by Radiographic Disease Assessments Per Modified RECIST v1.1
ORR was defined as the percentage of participants having a complete response (CR) or partial response (PR) as determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Intent-to-Treat Population: All subjects who are enrolled in the Phase 1 portion of the study. Treatment groups for this population were defined according to the treatment assignment at the time of enrollment on Day 1 regardless of the actual study drug the subject received during his/her continued participation in the study.
Posted
Count of Participants
Participants
Measured every 8 weeks for duration of study treatment [approximately 6 months]
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Secondary
Phase 2: Number of Treatment-Emergent Adverse Events
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
The Phase 2 safety population includes all subjects enrolled in the Phase 2 portion of the study who received at least 1 dose of INCB024360 or MEDI4736.
Posted
Count of Participants
Participants
Continuously for duration of study treatment and up to 90 days after the last dose [approximately 3 years]
ID
Title
Description
OG000
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG001
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Participants
Secondary
Phase 1 and 2: Durability of Response as Measured by the Time From the Earliest Date of Disease Response Until Earliest Date of Disease Progression
Defined as the time from earliest date of disease response until the earliest date of disease progression per RECIST v1.1, or death due to any cause, if occurring sooner than progression.
Intent-to-Treat Population: All subjects who are enrolled in the Phase 1 & 2 portion of the study. Treatment groups were defined at the time of enrollment on Day 1 according to the treatment assignment for Phase 1 and according to the tumor type for phase 2.
Posted
Median
95% Confidence Interval
months
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Secondary
Phase 1 and 2: Progression-free Survival as Measured by the Duration From the Date of Enrollment Until the Earliest Date of Disease Progression or Death
Intent-to-Treat Population: All subjects who are enrolled in the Phase 1 & 2 portion of the study. Treatment groups were defined at the time of enrollment on Day 1 according to the treatment assignment for Phase 1 and according to the tumor type for phase 2.
Posted
Median
95% Confidence Interval
Months
Measured every 8 weeks for duration of active study treatment [approximately 24 months]
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Secondary
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Peak Concentration
The PK evaluable population will include all subjects who received at least 1 dose of INCB024360 and provided at least 1 post dose plasma sample (1 PK/PD measurement). Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)" Arm/Group were combined with the data collected from participants in the "Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)" Arm/Group for PK Analysis.
Posted
Mean
Standard Deviation
nM
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 or 10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Secondary
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Measured by Time to Maximal Observed Concentration
The PK evaluable population will include all subjects who received at least 1 dose of INCB024360 and provided at least 1 post dose plasma sample (1 PK/PD measurement). Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)" Arm/Group were combined with the data collected from participants in the "Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)" Arm/Group for PK Analysis.
Posted
Median
Full Range
hours
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 or 10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Secondary
Phase 1 and 2: Pharmacokinetics (PK) of INCB024360 as Area Under the Concentration-time Curve
The PK evaluable population will include all subjects who received at least 1 dose of INCB024360 and provided at least 1 post dose plasma sample (1 PK/PD measurement). Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)" Arm/Group were combined with the data collected from participants in the "Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)" Arm/Group for PK Analysis.
Posted
Mean
Standard Deviation
h*nM
Pre dose, 0.5, 1,2, 4.6.& 8 hrs Post dose on C1D1,C1D8,C2D1
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 or 10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Secondary
Phase 1 and 2: Immunogenicity of MEDI4736 as Measured by the Number and Percentage of Subjects Who Develop Detectable Anti-drug Antibodies (ADAs)
Evaluable Patients Post-Baseline: Treatment-Induced ADA - Patients who had baseline negative ADA result who developed anti-drug antibodies at any time after initial drug administration.
Posted
Count of Participants
Participants
Measured at defined study visits from Cycle 1 Day 1 through cycle 2 [approximately 2 weeks].
ID
Title
Description
OG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG003
Time Frame
Duration of study treatment and up to 90 days after the last dose [approximately 3 years]
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Phase I : Epacadostat (25 mg) + Durvalumab (3 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (3 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
5
6
2
6
6
6
EG001
Phase I : Epacadostat (25 mg) + Durvalumab (10 mg/kg)
Epacadostat (25 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
3
3
0
3
3
3
EG002
Phase I : Epacadostat (50 mg) + Durvalumab (10 mg/kg)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
1
4
2
4
4
4
EG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
4
4
0
4
4
4
EG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
6
8
4
8
8
8
EG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
5
9
3
9
9
9
EG006
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
35
49
20
49
48
49
EG007
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
58
93
54
93
87
93
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected4 at risk
EG0042 events2 affected8 at risk
EG0050 events0 affected9 at risk
EG0064 events3 affected49 at risk
EG0071 events1 affected93 at risk
Agitation
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Angiopathy
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Bile duct stenosis
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood calcium increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Chest pain
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Contrast media reaction
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Depressed level of consciousness
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Device related sepsis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Disease progression
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Embolism
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Face oedema
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypertensive emergency
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Large intestinal obstruction
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Localised oedema
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Lung infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Multi-organ failure
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pharyngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Polyneuropathy
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pulmonary haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pulseless electrical activity
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Squamous cell carcinoma of head and neck
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Stridor
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vision blurred
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal distension
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected4 at risk
EG0042 events2 affected8 at risk
EG0050 events0 affected9 at risk
EG0062 events2 affected49 at risk
EG0074 events4 affected93 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Amylase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Asthenia
General disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood albumin decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood potassium decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood prolactin abnormal
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Blood testosterone decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Candida infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Cataract
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Catheter site discharge
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Chills
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Conjunctivitis allergic
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0011 events1 affected3 at risk
EG0022 events2 affected4 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0012 events2 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0003 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Dry eye
Eye disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0012 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Ejection fraction decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Eye infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Face oedema
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 17.1
Systematic Assessment
EG0004 events4 affected6 at risk
EG0011 events1 affected3 at risk
EG0023 events2 affected4 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Foreign body aspiration
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected4 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypogonadism
Endocrine disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Impaired gastric emptying
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Influenza like illness
General disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Laryngeal inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Lipase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Lower urinary tract symptoms
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Malignant ascites
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0004 events4 affected6 at risk
EG0011 events1 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events1 affected4 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Peritumoural oedema
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Pyrexia
General disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0022 events2 affected4 at risk
EG003
Rales
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0023 events1 affected4 at risk
EG003
Rhonchi
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Serotonin syndrome
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Skin infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Sputum discoloured
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Syncope
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Throat irritation
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Transaminases increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected4 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected4 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0034
OG0048
OG0059
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0052
OG00049
OG00193
Title
Denominators
Categories
Title
Measurements
OG00049
OG00193
Epacadostat (50 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG006
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG007
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Participants
OG0001
OG0010
OG0021
OG0030
OG0041
OG0052
OG0066
OG00712
Title
Denominators
Categories
Title
Measurements
OG0001.9(NA to NA)Upper and Lower bound not estimable due to sample size
OG002NA(NA to NA)Median not estimable due to censoring
OG004NA(NA to NA)Median not estimable due to censoring
OG005NA(25.6 to NA)Median not estimable due to censoring
OG00613.8(8.5 to NA)Due to the definition of confidence interval in SAS proc lifetest, the time point satisfying the upper bound from the formula happens to be censored, therefore it is not NE
OG007NA(1.9 to NA)Median duration and Upper bound is not estimable due to due to the many censored observations
OG003
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG006
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG007
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Participants
OG0006
OG0013
OG0024
OG0034
OG0048
OG0059
OG00649
OG00793
Title
Denominators
Categories
Title
Measurements
OG0002.4(1.3 to 7.3)
OG00112.0(1.8 to NA)Due to the definition of confidence interval in SAS proc lifetest, the time point satisfying the upper bound from the formula happens to be censored, therefore it is not estimable
OG0021.9(1.1 to NA)Due to the definition of confidence interval in SAS proc lifetest, the time point satisfying the upper bound from the formula happens to be censored, therefore it is not estimable
OG0031.7(0.5 to 5.9)
OG0044.1(0.7 to NA)Due to the definition of confidence interval in SAS proc lifetest, the time point satisfying the upper bound from the formula happens to be censored, therefore it is not estimable
OG0052.5(1.1 to 27.2)
OG0061.9(1.7 to 2.3)
OG0072.1(1.9 to 3.7)
OG003
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG006
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Participants
OG0008
OG0013
OG0023
OG0037
OG0047
OG00538
OG00636
Title
Denominators
Categories
Title
Measurements
OG000273± 65.3
OG001248± 135
OG002604± 493
OG003727± 403
OG0042660± 1200
OG005960± 499
OG0062500± 1190
OG003
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG006
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Participants
OG0008
OG0013
OG0023
OG0037
OG0047
OG00538
OG00636
Title
Denominators
Categories
Title
Measurements
OG0002.0(1.0 to 2.2)
OG0012.0(1.0 to 3.8)
OG0021.9(0.017 to 3.9)
OG0032.0(0.92 to 6.0)
OG0043.3(1.2 to 6.0)
OG0052.0(0.0 to 5.7)
OG0062.1(0.52 to 5.5)
OG003
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG005
Phase II : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
OG006
Phase II : Epacadostat (300 mg) + Durvalumab (10 mg/kg)
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle in select tumor types.
Units
Counts
Participants
OG0008
OG0013
OG0023
OG0037
OG0047
OG00536
OG00634
Title
Denominators
Categories
Title
Measurements
OG0001040± 345
OG0011580± 739
OG0023090± 1880
OG0033650± 2710
OG00415400± 6770
OG0054130± 1960
OG00612200± 5950
Phase I : Epacadostat (75 mg) + Durvalumab (10 mg/kg)Edit
Epacadostat (75 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
OG004
Phase I : Epacadostat (100 mg) + Durvalumab (10 mg/kg)
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle
OG005
Phase I : Epacadostat (300 mg) + Durvalumab (10 mg/kg)Edit
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle.
Epacadostat (100 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle to determine maximum Tolerated dose (MTD) or pharmacologically active dose (PAD).
Epacadostat (300 mg) oral twice-daily (BID) dosing in combination with durvalumab (10 mg/kg) administered intravenously (IV) on Day 1 of each 14 day cycle to determine maximum Tolerated dose (MTD) or pharmacologically active dose (PAD).