An Open-Label, Dose-Escalation/Dose-Expansion Safety Stud... | NCT02712905 | Trialant
NCT02712905
Sponsor
Incyte Corporation
Status
Terminated
Last Update Posted
Nov 4, 2025Actual
Enrollment
116Actual
Phase
Phase 1Phase 2
Conditions
Solid Tumors and Hematologic Malignancy
Interventions
INCB059872
all-trans retinoic acid (ATRA)
azacitidine
nivolumab
Countries
United States
Belgium
Netherlands
Protocol Section
Identification Module
NCT ID
NCT02712905
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
INCB 59872-101
Secondary IDs
ID
Type
Description
Link
2017-001710-28
EudraCT Number
Brief Title
An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies
Official Title
A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies
Acronym
Not provided
Organization
Incyte CorporationINDUSTRY
Status Module
Record Verification Date
Oct 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Strategic Business Decision
Expanded Access Info
No
Start Date
May 5, 2016Actual
Primary Completion Date
Apr 14, 2022Actual
Completion Date
Apr 14, 2022Actual
First Submitted Date
Feb 18, 2016
First Submission Date that Met QC Criteria
Mar 15, 2016
First Posted Date
Mar 18, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 10, 2023
Results First Submitted that Met QC Criteria
May 15, 2023
Results First Posted Date
Jun 12, 2023Actual
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
Oct 20, 2025
Last Update Posted Date
Nov 4, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Incyte CorporationINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, dose-escalation/dose-expansion study of INCB059872 in subjects with advanced malignancies. The study will be conducted in 4 parts. Part 1 (mono therapy dose escalation) will determine the recommended dose(s) of INCB059872 for dose expansion, based on maximum tolerated dose and/or a tolerated pharmacologically active dose. Part 2 (dose expansion) will further determine the safety, tolerability, efficacy, PK, and PD of the selected monotherapy dose(s) in AML/MDS, SCLC, myelofibrosis, Ewing sarcoma, and poorly differentiated neuroendocrine tumors. Part 3 will determine the recommended dose(s) of INCB059872 in combination with azacitadine and all-trans retinoic acid in AML and in combination with nivolumab in SCLC. Part 4 will further determine the safety, tolerability, efficacy, PK, and PD of the selected combination dose(s) in Part 3.
Initial cohort dose of INCB059872 to evaluate different doses of INCB0599872 in combination with other therapies in the following treatment groups:
Combination with all-trans retinoic acid (ATRA) in subjects with relapsed/refractory AML.
Combination with azacitidine in subjects with newly diagnosed, treatment-naive AML
Combination with nivolumab in subjects with advanced SCLC previously progressed on platinum-based treatment.
Upon identification of the recommended dose(s) for each treatment combination, expansion cohorts of approximately 30 subjects in each treatment group may begin enrollment to further determine safety, tolerability, efficacy, PK, and PD of the selected dose(s).
Drug: INCB059872
Drug: all-trans retinoic acid (ATRA)
Drug: azacitidine
Drug: nivolumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
INCB059872
Drug
Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.
INCB059872 tablets to be administered by mouth.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
up to 588 days
Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
up to 1387 days
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female subjects, age 18 years or older.
Presence of measurable disease that has been confirmed by histology or cytology.
Must not be a candidate for potentially curative therapy or standard-of-care approved therapy
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Exclusion Criteria:
Receipt of anticancer medications, anticancer therapies, or investigational drugs within the defined interval before the first administration of study drug.
Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for stable chronic toxicities (≤ Grade 2) not expected to resolve.
Laboratory and medical history parameters outside Protocol-defined range.
Known additional malignancy that is progressing or requires active treatment.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Fred Zheng, MD
Incyte Corporation
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama
Birmingham
Alabama
35487
United States
Moores UCSD Cancer Center
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Participants were enrolled at 12 study sites: 10 in the United States and 1 each in Belgium and the Netherlands.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
FG001
Group A: INCB059872 Monotherapy; 2 mg QD
Periods
Title
Milestones
Reasons Not Completed
Monotherapy
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jun 15, 2020
Apr 10, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
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
INCB059872
INCB059872 in combination with other therapies
all-trans retinoic acid (ATRA)
Drug
INCB059872 in combination with other therapies
azacitidine
Drug
INCB059872 in combination with other therapies
nivolumab
Drug
INCB059872 in combination with other therapies
up to 518 days
ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10^9/Liter (L), platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.
up to 85 days
ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.
up to 61 days
Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy
Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.
Baseline; Week 12
Cmax of INCB059872 in Plasma When Received as Monotherapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Tmax of INCB059872 in Plasma When Received as Monotherapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
AUC(0-Ï„) of INCB059872 in Plasma When Received as Monotherapy
AUC(0-Ï„) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
t1/2 of INCB059872 in Plasma When Received as Monotherapy
t1/2 was defined as the half-life of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
CL/F of INCB059872 in Plasma When Received as Monotherapy
CL/F was defined as the apparent oral clearance of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ORR in Participants With SCLC Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
up to 1353 days
ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10^9/L, platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.
up to 208 days
ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.
up to 85 days
Cmax of INCB059872 in Plasma When Received as Combination Therapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
Tmax of INCB059872 in Plasma When Received as Combination Therapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
AUC(0-Ï„) of INCB059872 in Plasma When Received as Combination Therapy
AUC(0-Ï„) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
t1/2 of INCB059872 in Plasma When Received as Combination Therapy
t1/2 was defined as the half-life of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
CL/F of INCB059872 in Plasma When Received as Combination Therapy
CL/F was defined as the apparent oral clearance of INCB059872.
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
La Jolla
California
92093
United States
UCLA Medical Center
Los Angeles
California
90095
United States
Northwestern University
Chicago
Illinois
60208
United States
University of Kansas Center for Research, Inc.
Kansas City
Kansas
66045
United States
Roswell Park Cancer Institute
Buffalo
New York
14263
United States
Columbia University
New York
New York
10027
United States
Oregon Health Science University
Portland
Oregon
97297
United States
University of Pennsylvania
Philadelphia
Pennsylvania
19104
United States
Vanderbilt University
Nashville
Tennessee
37240
United States
University of Texas MD Anderson Cancer Center
Houston
Texas
77030
United States
Institut Jules Bordet
Brussels
Belgium
Netherland Cancer Institute
Amsterdam
Netherlands
VU Medical Center
Amsterdam
Netherlands
Erasmus MC
Rotterdam
Netherlands
Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
FG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
FG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
FG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
FG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
FG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
FG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
FG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
FG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
FG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
FG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
FG012
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
FG013
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
FG014
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
FG015
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
FG016
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
FG017
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
FG0003 subjects
FG0016 subjects
FG0021 subjects
FG0035 subjects
FG00418 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
FG0081 subjects
FG00936 subjects
FG0103 subjects
FG0117 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0021 subjects
FG0035 subjects
FG00418 subjects
FG0052 subjects
FG0063 subjects
FG0073 subjects
FG0081 subjects
FG00936 subjects
FG0103 subjects
FG0117 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Type
Comment
Reasons
Death
FG0002 subjects
FG0015 subjects
FG0020 subjects
FG0033 subjects
FG00415 subjects
FG0051 subjects
FG0063 subjects
FG0073 subjects
FG0080 subjects
FG00927 subjects
FG0102 subjects
FG0115 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Started New Cancer Drug
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Combination Therapy
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0125 subjects
FG0137 subjects
FG0141 subjects
FG0157 subjects
FG0161 subjects
FG0176 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
BG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
BG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
BG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
BG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
BG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
BG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
BG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
BG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
BG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
BG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
BG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received oral INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
BG012
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
BG013
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
BG014
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
BG015
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
BG016
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
BG017
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
BG018
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0021
BG0035
BG00418
BG0052
BG0063
BG0073
BG0081
BG00936
BG0103
BG0117
BG0125
BG0137
BG0141
BG0157
BG0161
BG0176
BG018115
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
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0021
ParticipantsBG003
Sex: Female, Male
For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Ethnicity (NIH/OMB)
For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Race/Ethnicity, Customized
For treatment arms in which a single participant was enrolled, data have not been reported due to privacy concerns (denoted Number Analyzed=0 for treatment arm).
Count of Participants
Participants
Title
Denominators
Categories
White
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Receiving INCB059872 Monotherapy With Any Treatment-emergent Adverse Event (TEAE)
Adverse events (AEs) were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
Safety Population: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab
Posted
Count of Participants
Participants
up to 588 days
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0003
OG0016
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0016
OG0021
OG003
Primary
Number of Participants Receiving INCB059872 Combination Therapy With Any TEAE
AEs were defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). TEAEs were defined as AEs either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug.
Safety Population
Posted
Count of Participants
Participants
up to 1387 days
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
Objective Response Rate (ORR) in Participants With the Indicated Type of Solid Tumors Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or a partial response (PR), per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RESIST v1.1), recorded before and including the first event of progressive disease (PD). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Full Analysis Set: all enrolled participants who received at least 1 dose of INCB059872, ATRA, azacitidine, or nivolumab. Only participants with the indicated type of solid tumor who received monotherapy were analyzed.
Posted
Number
percentage of participants
up to 518 days
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Secondary
ORR for Altering the Natural History of the Disease in Participants With Acute Myeloid Leukemia (AML) Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission or complete remission with incomplete hematologic recovery (CRi), per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: absolute neutrophil count (ANC) ≥1.0 x 10^9/Liter (L), platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.
Full Analysis Set. Only participants with AML who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.
Posted
Number
percentage of participants
up to 85 days
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Secondary
ORR for Altering the Natural History of the Disease in Participants With Myelodysplastic Syndrome (MDS) Who Received INCB059872 Monotherapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 grams per deciliter (g/dL), neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.
Full Analysis Set. Only participants with MDS who received monotherapy were analyzed. The participant in Group A receiving 3 mg QOD was on treatment for less than a week and therefore was not evaluated for efficacy.
Posted
Number
percentage of participants
up to 61 days
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Secondary
Change From Baseline in Spleen Volume Reduction (SVR) at Week 12 in Participants With Myelofibrosis (MF) Who Received INCB059872 Monotherapy
Change from Baseline was to have been calculated as the post-Baseline value minus the Baseline value. SVR was to have been measured by magnetic resonance imaging (MRI), or by computed tomography (CT) scan in participants who were not candidates for MRI or when MRI was not readily available.
Full Analysis Set. Analysis was not conducted because no participants with MF remained in the study at Week 12.
Posted
Baseline; Week 12
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Secondary
Cmax of INCB059872 in Plasma When Received as Monotherapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
Pharmacokinetic (PK)-Evaluable Population: all participants who received at least 1 dose of study treatment and provided at least 1 postdose PK sample
Posted
Mean
Standard Deviation
nanomolar (nM)
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Secondary
Tmax of INCB059872 in Plasma When Received as Monotherapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
Pharmacokinetic (PK)-Evaluable Population
Posted
Median
Full Range
hours
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Secondary
AUC(0-Ï„) of INCB059872 in Plasma When Received as Monotherapy
AUC(0-Ï„) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
nM x hour
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Secondary
t1/2 of INCB059872 in Plasma When Received as Monotherapy
t1/2 was defined as the half-life of INCB059872.
Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
hours
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Secondary
CL/F of INCB059872 in Plasma When Received as Monotherapy
CL/F was defined as the apparent oral clearance of INCB059872.
Pharmacokinetic (PK)-Evaluable Population. Only participants with available data were analyzed.
Posted
Mean
Standard Deviation
Liters per hour
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
OG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Secondary
ORR in Participants With SCLC Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of CR or a PR, per investigator assessment according to RESIST v1.1, recorded before and including the first event of PD. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to <10 mm. PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
Full Analysis Set. Only participants with SCLC who received combination therapy and had available data were analyzed.
Posted
Number
percentage of participants
up to 1353 days
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
ORR for Altering the Natural History of the Disease in Participants With AML Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission or CRi, per the International Working Group Response Criteria for AML, recorded before and including the first event of progression (treatment failure, relapse, and PD) based on altering the natural history of the disease. Complete remission: ANC ≥1.0 x 10^9/L, platelet count ≥100 x 10^9/L, bone marrow with less than 5% blast cells, Auer rods not detectable; no platelet, or whole blood transfusions for 7 days prior to the date of the hematology assessment. CRi: complete remission, but the ANC count may be < 1.0 x 10^9/L and/or the platelet count may be <100 x 10^9/L.
Full Analysis Set. Only participants with AML who received combination therapy were analyzed.
Posted
Number
percentage of participants
up to 208 days
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
ORR for Altering the Natural History of the Disease in Participants With MDS Who Received Combination Therapy
ORR was defined as the percentage of participants who achieved a best overall response of complete remission, partial remission, or bone marrow complete remission, per the International Working Group Response Criteria for MDS, recorded before and including the first event of progression (treatment failure, relapse after CR or PR, disease transformation, and PD) based on altering the natural history of the disease. Complete remission: <5% bone marrow blasts without evidence of dysplasia; peripheral blood counts: hemoglobin ≥11 g/dL, neutrophils ≥1 x 10^9/L, platelets ≥100 x 10^9/L. Partial remission: meeting complete remission criteria, but bone marrow blasts decreased by ≥50% from pre-treatment, but still ≥5%. Bone marrow complete remission: ≤5% bone marrow blasts and decrease by ≥50% from pre-treatment.
Full Analysis Set. Only participants with MDS who received combination therapy were analyzed.
Posted
Number
percentage of participants
up to 85 days
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Secondary
Cmax of INCB059872 in Plasma When Received as Combination Therapy
Cmax was defined as the maximum observed plasma concentration of INCB059872.
PK-Evaluable Population
Posted
Mean
Standard Deviation
nM
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
Tmax of INCB059872 in Plasma When Received as Combination Therapy
tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
PK-Evaluable Population
Posted
Median
Full Range
hours
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
AUC(0-Ï„) of INCB059872 in Plasma When Received as Combination Therapy
AUC(0-Ï„) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
PK-Evaluable Population
Posted
Mean
Standard Deviation
nM x hour
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
t1/2 of INCB059872 in Plasma When Received as Combination Therapy
t1/2 was defined as the half-life of INCB059872.
PK-Evaluable Population
Posted
Mean
Standard Deviation
hours
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Secondary
CL/F of INCB059872 in Plasma When Received as Combination Therapy
CL/F was defined as the apparent oral clearance of INCB059872.
PK-Evaluable Population
Posted
Mean
Standard Deviation
Liters per hour
Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
ID
Title
Description
OG000
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG001
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
Time Frame
up to 1387 days
Description
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last administration of study drug, have been reported for the Safety Population.
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
Group A: INCB059872 Monotherapy; 2 mg QOD
Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received INB059872 2 milligrams (mg) as monotherapy once every other day (QOD) on a 28-day continuous therapy cycle.
2
3
1
3
3
3
EG001
Group A: INCB059872 Monotherapy; 2 mg QD
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
5
6
5
6
6
6
EG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
0
1
0
1
1
1
EG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
4
5
3
5
5
5
EG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
15
18
10
18
17
18
EG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
2
2
2
2
2
2
EG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
3
3
2
3
3
3
EG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
3
3
1
3
3
3
EG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
0
1
1
1
1
1
EG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
27
36
24
36
35
36
EG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
2
3
2
3
3
3
EG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
5
7
3
7
7
7
EG012
Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
Participants with relapsed/refractory AML received INCB059872 2 mg QD in combination with all-trans retinoic acid (ATRA) (at a starting dose of 45 mg/meters squared [m^2] per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
5
5
4
5
4
5
EG013
Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
6
7
4
7
7
7
EG014
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
1
1
0
1
1
1
EG015
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
3
7
6
7
7
7
EG016
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
1
1
1
1
1
1
EG017
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
3
6
2
6
6
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected3 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected1 at risk
EG0093 events3 affected36 at risk
EG0101 events1 affected3 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected1 at risk
EG0150 events0 affected7 at risk
EG0160 events0 affected1 at risk
EG0170 events0 affected6 at risk
Acute febrile neutrophilic dermatosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Adrenal haemorrhage
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Atypical pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Biliary obstruction
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blast cell crisis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cholangitis
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Enterococcal bacteraemia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Escherichia bacteraemia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
General physical health deterioration
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hepatic failure
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Klebsiella bacteraemia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Myasthenic syndrome
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary alveolar haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Sepsis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Septic shock
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Staphylococcal skin infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Swollen tongue
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Temporomandibular joint syndrome
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tongue haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection bacterial
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract obstruction
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected3 at risk
EG0071 events1 affected3 at risk
EG0080 events0 affected1 at risk
EG0090 events0 affected36 at risk
EG0100 events0 affected3 at risk
EG0110 events0 affected7 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected1 at risk
EG0150 events0 affected7 at risk
EG0160 events0 affected1 at risk
EG0170 events0 affected6 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Actinomycosis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Activated partial thromboplastin time prolonged
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Adrenal insufficiency
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Asthenia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Atrial enlargement
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Axillary pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blood blister
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Blood thyroid stimulating hormone
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blood triglycerides increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Blood urea increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Breast pain
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Breast tenderness
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Catheter site cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cheilitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Chest discomfort
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Chest pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Chills
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Chondrocalcinosis
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Deafness neurosensory
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Depression
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dysgeusia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Eye inflammation
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Eye irritation
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Face oedema
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Fatigue
General disorders
MedDRA 25.1
Systematic Assessment
EG0003 events3 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Fungal infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gait disturbance
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gingival hypertrophy
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gingival pain
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haematoma
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haemorrhagic diathesis
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Headache
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Hernia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hiccups
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypertension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypotension
Vascular disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Influenza like illness
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Injection site erythema
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Injection site reaction
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Iron deficiency
Metabolism and nutrition disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Laryngeal haemorrhage
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Lip dry
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Lymph node pain
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Nail disorder
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Nail infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 events2 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Nocturia
Renal and urinary disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oedema
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oedema peripheral
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oesophageal fistula
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oral blood blister
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pain
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Palmar erythema
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Paraesthesia oral
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pericardial effusion
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Peripheral swelling
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Platelet count increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Post procedural haemorrhage
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Prothrombin time prolonged
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected1 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pulmonary oedema
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Pyrexia
General disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Synovial rupture
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Taste disorder
Nervous system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tongue haematoma
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0001 events1 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Transfusion reaction
Injury, poisoning and procedural complications
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Tricuspid valve incompetence
Cardiac disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Troponin I increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Troponin increased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vision blurred
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vitiligo
Skin and subcutaneous tissue disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vitreous floaters
Eye disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 25.1
Systematic Assessment
EG0002 events1 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Weight decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0012 events2 affected6 at risk
EG0020 events0 affected1 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
White blood cell count decreased
Investigations
MedDRA 25.1
Systematic Assessment
EG0000 events0 affected3 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected1 at risk
EG003
The study was terminated by the sponsor due to a strategic business decision.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
Unknown; Did Not Complete End of Study Case Report Form Prior to Site Closure
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
5
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0081
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0141
ParticipantsBG0157
ParticipantsBG0161
ParticipantsBG0176
ParticipantsBG018115
Title
Measurements
BG00065.0± 5.20
BG00158.0± 9.53
BG002NA± NAUnable to report age for a single participant due to privacy concerns.
BG00357.4± 21.93
BG00463.8± 12.02
BG00551.0± 18.38
BG00646.3± 22.59
BG00763.0± 17.09
BG008NA± NAUnable to report age for a single participant due to privacy concerns.
BG00957.8± 13.95
BG01051.0± 11.53
BG01163.0± 4.86
BG01261.0± 9.19
BG01363.6± 13.83
BG014NA± NAUnable to report age for a single participant due to privacy concerns.
BG01573.4± 9.02
BG016NA± NAUnable to report age for a single participant due to privacy concerns.
BG01768.7± 9.48
BG01860.8± 13.39
0
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
Female
BG0003
BG0013
BG0033
BG0049
BG0052
BG0061
BG0073
BG00916
BG0100
BG0114
BG0120
BG0134
BG0153
BG0173
BG01854
Male
BG0000
BG0013
BG0032
BG0049
BG005
0
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0030
BG0042
BG0051
BG0060
BG0070
BG0090
BG0100
BG0110
BG0120
BG0130
BG0150
BG0170
BG0184
Not Hispanic or Latino
BG0003
BG0015
BG0035
BG00416
BG005
Unknown or Not Reported
BG0000
BG0010
BG0030
BG0040
BG005
0
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0003
BG0014
BG0034
BG00415
BG0052
BG0062
BG0072
BG00931
BG0103
BG0116
BG0125
BG0136
BG0157
BG0176
BG01896
Black or African American
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0020
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0000
BG0012
BG0030
BG004
Asian
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0020
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0000
BG0010
BG0030
BG004
American-Indian/Alaska Native
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0020
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0000
BG0010
BG0030
BG004
Non-White
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0020
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0000
BG0010
BG0031
BG004
Unknown/Not Specified
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0020
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0000
BG0010
BG0030
BG004
Declined to Report
ParticipantsBG0003
ParticipantsBG0016
ParticipantsBG0020
ParticipantsBG0035
ParticipantsBG00418
ParticipantsBG0052
ParticipantsBG0063
ParticipantsBG0073
ParticipantsBG0080
ParticipantsBG00936
ParticipantsBG0103
ParticipantsBG0117
ParticipantsBG0125
ParticipantsBG0137
ParticipantsBG0140
ParticipantsBG0157
ParticipantsBG0160
ParticipantsBG0176
ParticipantsBG018111
Title
Measurements
BG0000
BG0010
BG0030
BG004
5
OG00418
OG0052
OG0063
OG0073
OG0081
OG00936
OG0103
OG0117
5
OG00418
OG0052
OG0063
OG0073
OG0081
OG00936
OG0103
OG0117
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0005
OG0017
OG0021
OG0037
OG0041
OG0056
Title
Denominators
Categories
Title
Measurements
OG0005
OG0017
OG0021
OG0037
OG0041
OG0056
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0063
OG0073
OG0081
OG00936
OG0103
OG0117
Title
Denominators
Categories
SCLC
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
ParticipantsOG0060
ParticipantsOG0070
ParticipantsOG0080
ParticipantsOG00918
ParticipantsOG0101
ParticipantsOG0113
Title
Measurements
OG0090.0
OG0100.0
OG0110.0
Ewing's sarcoma
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Poorly differentiated neuroendocrine tumors
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Other solid tumors
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0003
OG0015
OG0020
OG0034
OG00412
OG0052
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG0010.0
OG0030.0
OG0040.0
OG0050.0
Participants with AML or MDS received INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
OG002
Group A: INCB059872 Monotherapy; 3 mg QOD
Participants with AML or MDS received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0000
OG0011
OG0020
OG0031
OG0046
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Title
Denominators
Categories
Title
Measurements
OG0010.0
OG0030.0
OG0040.0
OG003
Group A: INCB059872 Monotherapy; 3 mg QD
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
OG0090
OG0100
OG0110
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0002
OG0014
OG0020
OG0033
OG0043
OG0051
OG0063
OG0073
OG0080
OG0096
OG0101
OG0113
Title
Denominators
Categories
Title
Measurements
OG00033.4± 29.2
OG00146.0± 12.5
OG00373.1± 30.5
OG004110± 13.7
OG005NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG00625.7± 21.8
OG00746.0± 9.95
OG00970.6± 25.6
OG010NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG01198.2± 28.5
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0002
OG0014
OG0020
OG0033
OG0043
OG0051
OG0063
OG0073
OG0080
OG0096
OG0101
OG0113
Title
Denominators
Categories
Title
Measurements
OG0000.5(0.5 to 0.5)
OG0011(0.5 to 1)
OG0031(0.5 to 1)
OG0040.5(0.5 to 1)
OG005NA(NA to NA)To protect participant privacy and mitigate the risk of re-identification, median (full range) cannot be reported for a single participant.
OG0062.0(0.5 to 2)
OG0072(0.5 to 2)
OG0091(0.5 to 2)
OG010NA(NA to NA)To protect participant privacy and mitigate the risk of re-identification, median (full range) cannot be reported for a single participant.
OG0110.5(0.5 to 1)
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0002
OG0014
OG0020
OG0033
OG0043
OG0051
OG0061
OG0071
OG0080
OG0096
OG0101
OG0113
Title
Denominators
Categories
Title
Measurements
OG000196± 8.38
OG001216± 75.5
OG003374± 120
OG004486± 107
OG005NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG006NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG007NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG009361± 115
OG010NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG011495± 63.2
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0002
OG0014
OG0020
OG0033
OG0043
OG0051
OG0061
OG0071
OG0080
OG0096
OG0101
OG0113
Title
Denominators
Categories
Title
Measurements
OG0003.15± 0.189
OG0013.30± 0.765
OG0033.13± 0.495
OG0043.67± 1.38
OG005NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG006NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG007NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG0093.57± 0.52
OG010NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG0114.28± 0.25
Participants with AML or MDS received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG004
Group A: INCB059872 Monotherapy; 4 mg QD
Participants with AML or MDS received INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG005
Group A: INCB059872 Monotherapy; 5 mg QD
Participants with AML or MDS received INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG006
Group B: INCB059872 Monotherapy; 1 mg QD
Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received INB059872 1 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG007
Group B: INCB059872 Monotherapy; 2 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG008
Group B: INCB059872 Monotherapy; 2 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 2 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG009
Group B: INCB059872 Monotherapy; 3 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
OG010
Group B: INCB059872 Monotherapy; 3 mg QD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
OG011
Group B: INCB059872 Monotherapy; 4 mg QOD
Participants with SCLC and other solid malignancies (e.g., endocrine tumors) received INB059872 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.
Units
Counts
Participants
OG0002
OG0014
OG0020
OG0033
OG0043
OG0051
OG0061
OG0071
OG0080
OG0096
OG0101
OG0113
Title
Denominators
Categories
Title
Measurements
OG00032.9± 7.94
OG00126.3± 9.31
OG00322.1± 6.56
OG00422.1± 5.57
OG005NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG006NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG007NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG00923.1± 6.32
OG010NA± NATo protect participant privacy and mitigate the risk of re-identification, mean (SD) cannot be reported for a single participant.
OG01121.1± 2.74
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0055
Title
Denominators
Categories
Title
Measurements
OG00520.0
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0005
OG0017
OG0021
OG0036
OG0041
OG0050
Title
Denominators
Categories
Title
Measurements
OG00020.0
OG0010.0
OG0020.0
OG00316.7
OG0040.0
Participants with relapsed/refractory AML received oral INCB059872 3 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG002
Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
Participants with relapsed/refractory AML received oral INCB059872 4 mg QD in combination with ATRA (at a starting dose of 45 mg/m^2 per day at 2 evenly divided doses) on a 28-day continuous therapy cycle.
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0031
OG0040
OG0050
Title
Denominators
Categories
Title
Measurements
OG0030.0
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0004
OG0012
OG0020
OG0033
OG0040
OG0055
Title
Denominators
Categories
Title
Measurements
OG00044.3± 16.4
OG00196.4± 10.7
OG00338.2± 33.5
OG00578.0± 26.3
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0004
OG0012
OG0020
OG0033
OG0040
OG0055
Title
Denominators
Categories
Title
Measurements
OG0001.0(0.5 to 1)
OG0010.5(0.5 to 0.5)
OG0030.5(0 to 1)
OG0051.0(0.5 to 1)
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0004
OG0012
OG0020
OG0033
OG0040
OG0055
Title
Denominators
Categories
Title
Measurements
OG000225± 85.9
OG001377± 25.7
OG003273± 24.4
OG005357± 97.5
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.
Units
Counts
Participants
OG0004
OG0012
OG0020
OG0033
OG0040
OG0055
Title
Denominators
Categories
Title
Measurements
OG0003.95± 0.499
OG0013.41± 0.281
OG0033.08± 0.040
OG0053.79± 0.852
OG003
Group D: Combination Therapy; INCB059872 2 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG004
Group D: Combination Therapy; INCB059872 3 mg QD + Azacitidine
Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 3 mg QD on a 28-day continuous therapy cycle in combination with azacitidine, administered at a starting dose of 75 mg/m^2 subcutaneously or intravenously for 7 days during the first 9-day period of each 28-day treatment cycle.
OG005
Group E: Combination Therapy; INCB059872 3 mg QOD + Nivolumab
Participants with SCLC received oral INCB059872 3 mg QOD on a 28-day continuous therapy cycle in combination with nivolumab, administered at 3 mg/kilogram (kg) intravenously over 60 minutes every 2 weeks of each 28-day treatment cycle.