Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 1/2, Open-Label, Dose-Escalation/Dose-Expansion, Safety and Tolerability Study of INCB059872 in Subjects With Advanced Malignancies

    Summary
    EudraCT number
    		 2017-001710-28
    Trial protocol
    		 BE  
    Global end of trial date
    14 Apr 2022

    Results information
    Results version number
    		 v1
    This version publication date
    26 Apr 2023
    First version publication date
    26 Apr 2023
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    INCB 59872-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Incyte Corporation
    Sponsor organisation address
    1801 Augustine Cutoff Drive, Wilmington, United States, 19803
    Public contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Scientific contact
    Study Director, Incyte Corporation, 1 8554633463, medinfo@incyte.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Apr 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Part 1: To evaluate the safety and tolerability and determine the recommended dose(s) of INCB059872 for further study in advanced malignancies. Part 2: To further evaluate the safety and tolerability of INCB059872 for further study in advanced malignancies. Part 3: To evaluate the safety and tolerability and determine the recommended dose of INCB059872 in combination with other therapies for further study in advanced malignancies. Part 4: To further evaluate the safety and tolerability of INCB059872 in combination with other therapies in advanced malignancies.
    Protection of trial subjects
    This study was to have been performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and conducted in adherence to the study Protocol, Good Clinical Practices as defined in Title 21 of the United States Code of Federal Regulations Parts 11, 50, 54, 56, and 312, as well as International Council for Harmonization Good Clinical Practice consolidated guidelines (E6) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 104
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Netherlands: 2
    Worldwide total number of subjects
    115
    EEA total number of subjects
    11
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    62
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were enrolled at 12 study sites: 10 in the United States and 1 each in Belgium and the Netherlands.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group A: INCB059872 Monotherapy; 2 mg QOD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group A: INCB059872 Monotherapy; 2 mg QD
    Arm description
    		 Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group A: INCB059872 Monotherapy; 3 mg QOD
    Arm description
    		 Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group A: INCB059872 Monotherapy; 3 mg QD
    Arm description
    		 Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group A: INCB059872 Monotherapy; 4 mg QD
    Arm description
    		 Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group A: INCB059872 Monotherapy; 5 mg QD
    Arm description
    		 Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group B: INCB059872 Monotherapy; 1 mg QD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group B: INCB059872 Monotherapy; 2 mg QOD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group B: INCB059872 Monotherapy; 2 mg QD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group B: INCB059872 Monotherapy; 3 mg QOD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group B: INCB059872 Monotherapy; 3 mg QD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group B: INCB059872 Monotherapy; 4 mg QOD
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Investigational medicinal product name
    ATRA
    Investigational medicinal product code
    Other name
    tretinoin
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg concentration

    Arm title
    		 Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATRA
    Investigational medicinal product code
    Other name
    tretinoin
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg concentration

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ATRA
    Investigational medicinal product code
    Other name
    tretinoin
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg concentration

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    25 mg/milliliter (mL) concentration

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Azacitidine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    25 mg/milliliter (mL) concentration

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Arm title
    		 Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    nivolumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 mg/mL concentration

    Investigational medicinal product name
    INCB059872
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg concentration

    Number of subjects in period 1
    		Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Started
    3
    6
    1
    5
    18
    2
    3
    3
    1
    36
    3
    7
    5
    7
    1
    7
    1
    6
    Completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Not completed
    3
    6
    1
    5
    18
    2
    3
    3
    1
    36
    3
    7
    5
    7
    1
    7
    1
    6
         Adverse event, serious fatal
    2
    5
    -
    3
    15
    1
    3
    3
    -
    27
    2
    5
    5
    6
    1
    3
    1
    3
         Physician decision
    1
    -
    -
    1
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    1
    -
    2
    -
    -
    -
    -
    4
    1
    2
    -
    -
    -
    1
    -
    2
         Unknown; No EOS Form Prior to Site Closure
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Study Terminated by Sponsor
    -
    -
    -
    -
    1
    -
    -
    -
    -
    2
    -
    -
    -
    1
    -
    2
    -
    1
         Started New Cancer Drug
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    1
    -
    -
    -
    -
    -
    2
    -
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Group A: INCB059872 Monotherapy; 2 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group A: INCB059872 Monotherapy; 2 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 3 mg QOD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 3 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 4 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 5 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.

    Reporting group title
    Group B: INCB059872 Monotherapy; 1 mg QD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 2 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 2 mg QD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 3 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 3 mg QD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 4 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
    Reporting group description
    		 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.

    Reporting group title
    Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine
    Reporting group description
    		 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.

    Reporting group title
    Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine
    Reporting group description
    		 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.

    Reporting group title
    Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Reporting group description
    		 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.

    Reporting group values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab Total
    Number of subjects
    		 3 6 1 5 18 2 3 3 1 36 3 7 5 7 1 7 1 6 115
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2 5 0 2 8 2 2 1 1 22 3 5 3 3 1 1 0 1 62
        From 65-84 years
    		 1 1 1 3 10 0 1 2 0 14 0 2 2 4 0 6 1 5 53
    Age Continuous
    120=Unable to report age for a single participant due to privacy concerns.
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ( 5.20 ) 58.0 ( 9.53 ) 120 ( 120 ) 57.4 ( 21.93 ) 63.8 ( 12.02 ) 51.0 ( 18.38 ) 46.3 ( 22.59 ) 63.0 ( 17.09 ) 120 ( 120 ) 57.8 ( 13.95 ) 51.0 ( 11.53 ) 63.0 ( 4.86 ) 61.0 ( 9.19 ) 63.6 ( 13.83 ) 120 ( 120 ) 73.4 ( 9.02 ) 120 ( 120 ) 68.7 ( 9.48 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 3 3 0 3 9 2 1 3 0 16 0 4 0 4 0 3 0 3 54
        Male
    		 0 3 0 2 9 0 2 0 0 20 3 3 5 3 0 4 0 3 57
        Not Being Reported Due to Privacy Concerns
    		 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 1 0 4
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 3 4 0 4 15 2 2 2 0 31 3 6 5 6 0 7 0 6 96
        Black or African American
    		 0 2 0 0 1 0 0 1 0 3 0 1 0 0 0 0 0 0 8
        Asian
    		 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 2
        American-Indian/Alaska Native
    		 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1
        Non-White
    		 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
        Unknown/Not Specified
    		 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 2
        Declined to Report
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1
        Not Being Reported Due to Privacy Concerns
    		 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 1 0 4
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 1 0 0 2 1 0 0 0 0 0 0 0 0 0 0 0 0 4
        Not Hispanic or Latino
    		 3 5 0 5 16 1 3 3 0 36 3 7 5 7 0 7 0 6 107
        Unknown or Not Reported
    		 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Not Being Reported Due to Privacy Concerns
    		 0 0 1 0 0 0 0 0 1 0 0 0 0 0 1 0 1 0 4

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Group A: INCB059872 Monotherapy; 2 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group A: INCB059872 Monotherapy; 2 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 2 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 3 mg QOD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 3 mg as monotherapy QOD on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 3 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 3 mg as monotherapy QD on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 4 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 4 mg as monotherapy QD on a 28-day continuous therapy cycle.

    Reporting group title
    Group A: INCB059872 Monotherapy; 5 mg QD
    Reporting group description
    		 Participants with AML or MDS received oral INB059872 5 mg as monotherapy QD on a 28-day continuous therapy cycle.

    Reporting group title
    Group B: INCB059872 Monotherapy; 1 mg QD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 2 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 2 mg QD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 3 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 3 mg QD
    Reporting group description
    		 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.

    Reporting group title
    Group B: INCB059872 Monotherapy; 4 mg QOD
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 2 mg QD + ATRA
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 3 mg QD + ATRA
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 4 mg QD + ATRA
    Reporting group description
    		 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.

    Reporting group title
    Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine
    Reporting group description
    		 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.

    Reporting group title
    Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine
    Reporting group description
    		 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.

    Reporting group title
    Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Reporting group description
    		 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.

    Primary: Number of participants receiving INCB059872 monotherapy with any treatment-emergent adverse event (TEAE)

    		 Close Top of page
    End point title
    		 Number of participants receiving INCB059872 monotherapy with any treatment-emergent adverse event (TEAE) [1] [2]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    up to 588 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed for this endpoint.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    3
    6
    1
    5
    18
    2
    3
    3
    1
    36
    3
    7
    Units: participants
    3
    6
    1
    5
    18
    2
    3
    3
    1
    36
    3
    7
    No statistical analyses for this end point

    Primary: Number of participants receiving INCB059872 combination therapy with any TEAE

    		 Close Top of page
    End point title
    		 Number of participants receiving INCB059872 combination therapy with any TEAE [3] [4]
    End point description
    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.
    End point type
    Primary
    End point timeframe
    up to 1387 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis was not performed for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    5
    7
    1
    7
    1
    6
    Units: participants
    5
    7
    1
    7
    1
    6
    No statistical analyses for this end point

    Secondary: Objective response rate (ORR) in participants with the indicated type of solid tumors who received INCB059872 monotherapy

    		 Close Top of page
    End point title
    		 Objective response rate (ORR) in participants with the indicated type of solid tumors who received INCB059872 monotherapy [5]
    End point description
    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. 9999=participants in treatment group did not have indicated type of solid tumor and thus did not contribute to the analysis. PDNTs=poorly differentiated neuroendocrine tumors.
    End point type
    Secondary
    End point timeframe
    up to 518 days
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    3 [12]
    3 [13]
    1 [14]
    36 [15]
    3 [16]
    7 [17]
    Units: percentage of participants
    number (not applicable)
        SCLC; Group B, n=0, 0, 0, 18, 1, 3
    9999
    9999
    9999
    0.0
    0.0
    0.0
        Ewing's sarcoma; Group B, n=0, 0, 0, 3, 0, 0
    9999
    9999
    9999
    0.0
    9999
    9999
        PDNTs; Group B, n=1, 0, 0, 12, 0, 0
    0.0
    9999
    9999
    0.0
    9999
    9999
        Other solid tumors; Group B, n=2, 3, 1, 3, 2, 4
    0.0
    0.0
    0.0
    0.0
    50.0
    0.0
    Notes
    [6] - Participants did not have solid tumors and thus did not contribute to the analysis.
    [7] - Participants did not have solid tumors and thus did not contribute to the analysis.
    [8] - Participants did not have solid tumors and thus did not contribute to the analysis.
    [9] - Participants did not have solid tumors and thus did not contribute to the analysis.
    [10] - Participants did not have solid tumors and thus did not contribute to the analysis.
    [11] - Participants did not have solid tumors and thus did not contribute to the analysis.
    [12] - Only participants with the indicated type of solid tumor contributed to the analysis.
    [13] - Only participants with the indicated type of solid tumor contributed to the analysis.
    [14] - Only participants with the indicated type of solid tumor contributed to the analysis.
    [15] - Only participants with the indicated type of solid tumor contributed to the analysis.
    [16] - Only participants with the indicated type of solid tumor contributed to the analysis.
    [17] - Only participants with the indicated type of solid tumor contributed to the analysis.
    No statistical analyses for this end point

    Secondary: ORR for altering the natural history of the disease in participants with acute myeloid leukemia (AML) who received INCB059872 monotherapy

    		 Close Top of page
    End point title
    		 ORR for altering the natural history of the disease in participants with acute myeloid leukemia (AML) who received INCB059872 monotherapy [18]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    up to 85 days
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    3 [19]
    5 [20]
    0 [21]
    4 [22]
    12 [23]
    2 [24]
    0 [25]
    0 [26]
    0 [27]
    0 [28]
    0 [29]
    0 [30]
    Units: percentage of participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    0.0
    Notes
    [19] - Only participants with AML contributed to the analysis.
    [20] - Only participants with AML contributed to the analysis.
    [21] - This participant was on treatment for less than a week and therefore was not evaluated for efficacy.
    [22] - Only participants with AML contributed to the analysis.
    [23] - Only participants with AML contributed to the analysis.
    [24] - Only participants with AML contributed to the analysis.
    [25] - Participants did not have AML and thus did not contribute to the analysis.
    [26] - Participants did not have AML and thus did not contribute to the analysis.
    [27] - Participants did not have AML and thus did not contribute to the analysis.
    [28] - Participants did not have AML and thus did not contribute to the analysis.
    [29] - Participants did not have AML and thus did not contribute to the analysis.
    [30] - Participants did not have AML and thus did not contribute to the analysis.
    No statistical analyses for this end point

    Secondary: ORR for altering the natural history of the disease in participants with myelodysplastic syndrome (MDS) who received INCB059872 monotherapy

    		 Close Top of page
    End point title
    		 ORR for altering the natural history of the disease in participants with myelodysplastic syndrome (MDS) who received INCB059872 monotherapy [31]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    up to 61 days
    Notes
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    0 [32]
    1
    0 [33]
    1
    6
    0 [34]
    0 [35]
    0 [36]
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    Units: percentage of participants
        number (not applicable)
    0.0
    0.0
    0.0
    Notes
    [32] - Participants did not have MDS and thus did not contribute to the analysis.
    [33] - This participant was on treatment for less than a week and therefore was not evaluated for efficacy.
    [34] - Participants did not have MDS and thus did not contribute to the analysis.
    [35] - Participants did not have MDS and thus did not contribute to the analysis.
    [36] - Participants did not have MDS and thus did not contribute to the analysis.
    [37] - Participants did not have MDS and thus did not contribute to the analysis.
    [38] - Participants did not have MDS and thus did not contribute to the analysis.
    [39] - Participants did not have MDS and thus did not contribute to the analysis.
    [40] - Participants did not have MDS and thus did not contribute to the analysis.
    No statistical analyses for this end point

    Secondary: Change from Baseline in spleen volume reduction (SVR) at Week 12 in participants with myelofibrosis (MF) who received INCB059872 monotherapy

    		 Close Top of page
    End point title
    		 Change from Baseline in spleen volume reduction (SVR) at Week 12 in participants with myelofibrosis (MF) who received INCB059872 monotherapy [41]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 12
    Notes
    [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    0 [42]
    0 [43]
    0 [44]
    0 [45]
    0 [46]
    0 [47]
    0 [48]
    0 [49]
    0 [50]
    0 [51]
    0 [52]
    0 [53]
    Units: centimeters cubed
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    ( )
    Notes
    [42] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [43] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [44] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [45] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [46] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [47] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [48] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [49] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [50] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [51] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [52] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    [53] - Analysis was not conducted because no participants with MF remained in the study at Week 12.
    No statistical analyses for this end point

    Secondary: Cmax of INCB059872 in plasma when received as monotherapy

    		 Close Top of page
    End point title
    		 Cmax of INCB059872 in plasma when received as monotherapy [54]
    End point description
    Cmax was defined as the maximum observed plasma concentration of INCB059872. 9999=Mean (SD) cannot be reported for a single participant.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [54] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    2
    4
    0 [55]
    3
    3
    1
    3
    3
    0 [56]
    6
    1
    3
    Units: nanomolar (nM)
        arithmetic mean (standard deviation)
    33.4 ( 29.2 )
    46.0 ( 12.5 )
    ( )
    73.1 ( 30.5 )
    110 ( 13.7 )
    9999 ( 9999 )
    25.7 ( 21.8 )
    46.0 ( 9.95 )
    ( )
    70.6 ( 25.6 )
    9999 ( 9999 )
    98.2 ( 28.5 )
    Notes
    [55] - No participants contributed to the analysis.
    [56] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: tmax of INCB059872 in plasma when received as monotherapy

    		 Close Top of page
    End point title
    		 tmax of INCB059872 in plasma when received as monotherapy [57]
    End point description
    tmax was defined as the time to the maximum observed plasma concentration of INCB059872. 9999=Median (full range) cannot be reported for a single participant.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [57] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    2
    4
    0 [58]
    3
    3
    1
    3
    3
    0 [59]
    6
    1
    3
    Units: hours
        median (full range (min-max))
    0.5 (0.5 to 0.5)
    1 (0.5 to 1)
    ( to )
    1 (0.5 to 1)
    0.5 (0.5 to 1)
    9999 (9999 to 9999)
    2.0 (0.5 to 2)
    2 (0.5 to 2)
    ( to )
    1 (0.5 to 2)
    9999 (9999 to 9999)
    0.5 (0.5 to 1)
    Notes
    [58] - No participants contributed to the analysis.
    [59] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: AUC(0-τ) of INCB059872 in plasma when received as monotherapy

    		 Close Top of page
    End point title
    		 AUC(0-τ) of INCB059872 in plasma when received as monotherapy [60]
    End point description
    AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872. 9999=Mean (SD) cannot be reported for a single participant.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [60] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    2
    4
    0 [61]
    3
    3
    1
    1
    1
    0 [62]
    6
    1
    3
    Units: nM x hour
        arithmetic mean (standard deviation)
    196 ( 8.38 )
    216 ( 75.5 )
    ( )
    374 ( 120 )
    486 ( 107 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    ( )
    361 ( 115 )
    9999 ( 9999 )
    495 ( 63.2 )
    Notes
    [61] - No participants contributed to the analysis.
    [62] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: t1/2 of INCB059872 in plasma when received as monotherapy

    		 Close Top of page
    End point title
    		 t1/2 of INCB059872 in plasma when received as monotherapy [63]
    End point description
    t1/2 was defined as the half-life of INCB059872. 9999=Mean (SD) cannot be reported for a single participant.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [63] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    2
    4
    0 [64]
    3
    3
    1
    1
    1
    0 [65]
    6
    1
    3
    Units: hours
        arithmetic mean (standard deviation)
    3.15 ( 0.189 )
    3.30 ( 0.765 )
    ( )
    3.13 ( 0.495 )
    3.67 ( 1.38 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    ( )
    3.57 ( 0.52 )
    9999 ( 9999 )
    4.28 ( 0.25 )
    Notes
    [64] - No participants contributed to the analysis.
    [65] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: CL/F of INCB059872 in plasma when received as monotherapy

    		 Close Top of page
    End point title
    		 CL/F of INCB059872 in plasma when received as monotherapy [66]
    End point description
    CL/F was defined as the apparent oral clearance of INCB059872. 9999=Mean (SD) cannot be reported for a single participant.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [66] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group A: INCB059872 Monotherapy; 2 mg QOD Group A: INCB059872 Monotherapy; 2 mg QD Group A: INCB059872 Monotherapy; 3 mg QOD Group A: INCB059872 Monotherapy; 3 mg QD Group A: INCB059872 Monotherapy; 4 mg QD Group A: INCB059872 Monotherapy; 5 mg QD Group B: INCB059872 Monotherapy; 1 mg QD Group B: INCB059872 Monotherapy; 2 mg QOD Group B: INCB059872 Monotherapy; 2 mg QD Group B: INCB059872 Monotherapy; 3 mg QOD Group B: INCB059872 Monotherapy; 3 mg QD Group B: INCB059872 Monotherapy; 4 mg QOD
    Number of subjects analysed
    2
    4
    0 [67]
    3
    3
    1
    1
    1
    0 [68]
    6
    1
    3
    Units: Liters per hour
        arithmetic mean (standard deviation)
    32.9 ( 7.94 )
    26.3 ( 9.31 )
    ( )
    22.1 ( 6.56 )
    22.1 ( 5.57 )
    9999 ( 9999 )
    9999 ( 9999 )
    9999 ( 9999 )
    ( )
    23.1 ( 6.32 )
    9999 ( 9999 )
    21.1 ( 2.74 )
    Notes
    [67] - No participants contributed to the analysis.
    [68] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: ORR in participants with SCLC who received combination therapy

    		 Close Top of page
    End point title
    		 ORR in participants with SCLC who received combination therapy [69]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    up to 1353 days
    Notes
    [69] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    0 [70]
    0 [71]
    0 [72]
    0 [73]
    0 [74]
    5 [75]
    Units: percentage of participants
        number (not applicable)
    20.0
    Notes
    [70] - Participants did not have SCLC and thus did not contribute to the analysis.
    [71] - Participants did not have SCLC and thus did not contribute to the analysis.
    [72] - Participants did not have SCLC and thus did not contribute to the analysis.
    [73] - Participants did not have SCLC and thus did not contribute to the analysis.
    [74] - Participants did not have SCLC and thus did not contribute to the analysis.
    [75] - Only participants with available data contributed to the analysis.
    No statistical analyses for this end point

    Secondary: ORR for altering the natural history of the disease in participants with AML who received combination therapy

    		 Close Top of page
    End point title
    		 ORR for altering the natural history of the disease in participants with AML who received combination therapy [76]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    up to 208 days
    Notes
    [76] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    5
    7
    1
    6 [77]
    1 [78]
    0 [79]
    Units: percentage of participants
        number (not applicable)
    20.0
    0.0
    0.0
    16.7
    0.0
    Notes
    [77] - Only participants with AML contributed to the analysis.
    [78] - Only participants with AML contributed to the analysis.
    [79] - Participants did not have AML and thus did not contribute to the analysis.
    No statistical analyses for this end point

    Secondary: ORR for altering the natural history of the disease in participants with MDS who received combination therapy

    		 Close Top of page
    End point title
    		 ORR for altering the natural history of the disease in participants with MDS who received combination therapy [80]
    End point description
    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.
    End point type
    Secondary
    End point timeframe
    up to 85 days
    Notes
    [80] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    0 [81]
    0 [82]
    0 [83]
    1 [84]
    0 [85]
    0 [86]
    Units: percentage of participants
        number (not applicable)
    0.0
    Notes
    [81] - Participants did not have MDS and thus did not contribute to the analysis.
    [82] - Participants did not have MDS and thus did not contribute to the analysis.
    [83] - Participants did not have MDS and thus did not contribute to the analysis.
    [84] - Only participants with MDS contributed to the analysis.
    [85] - Only participants with MDS contributed to the analysis.
    [86] - Participants did not have MDS and thus did not contribute to the analysis.
    No statistical analyses for this end point

    Secondary: Cmax of INCB059872 in plasma when received as combination therapy

    		 Close Top of page
    End point title
    		 Cmax of INCB059872 in plasma when received as combination therapy [87]
    End point description
    Cmax was defined as the maximum observed plasma concentration of INCB059872.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [87] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    4
    2
    0 [88]
    3
    0 [89]
    5
    Units: nM
        arithmetic mean (standard deviation)
    44.3 ( 16.4 )
    96.4 ( 10.7 )
    ( )
    38.2 ( 33.5 )
    ( )
    78.0 ( 26.3 )
    Notes
    [88] - No participants contributed to the analysis.
    [89] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: tmax of INCB059872 in plasma when received as combination therapy

    		 Close Top of page
    End point title
    		 tmax of INCB059872 in plasma when received as combination therapy [90]
    End point description
    tmax was defined as the time to the maximum observed plasma concentration of INCB059872.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [90] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    4
    2
    0 [91]
    3
    0 [92]
    5
    Units: hours
        median (full range (min-max))
    1.0 (0.5 to 1)
    0.5 (0.5 to 0.5)
    ( to )
    0.5 (0 to 1)
    ( to )
    1.0 (0.5 to 1)
    Notes
    [91] - No participants contributed to the analysis.
    [92] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: AUC(0-τ) of INCB059872 in plasma when received as combination therapy

    		 Close Top of page
    End point title
    		 AUC(0-τ) of INCB059872 in plasma when received as combination therapy [93]
    End point description
    AUC(0-τ) was defined as the area under the plasma concentration-time curve from time = 0 to the end of the dosing period of INCB059872.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [93] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    4
    2
    0 [94]
    3
    0 [95]
    5
    Units: nM x hour
        arithmetic mean (standard deviation)
    225 ( 85.9 )
    377 ( 25.7 )
    ( )
    273 ( 24.4 )
    ( )
    357 ( 97.5 )
    Notes
    [94] - No participants contributed to the analysis.
    [95] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: t1/2 of INCB059872 in plasma when received as combination therapy

    		 Close Top of page
    End point title
    		 t1/2 of INCB059872 in plasma when received as combination therapy [96]
    End point description
    t1/2 was defined as the half-life of INCB059872.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [96] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    4
    2
    0 [97]
    3
    0 [98]
    5
    Units: hours
        arithmetic mean (standard deviation)
    3.95 ( 0.499 )
    3.41 ( 0.281 )
    ( )
    3.08 ( 0.040 )
    ( )
    3.79 ( 0.852 )
    Notes
    [97] - No participants contributed to the analysis.
    [98] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Secondary: CL/F of INCB059872 in plasma when received as combination therapy

    		 Close Top of page
    End point title
    		 CL/F of INCB059872 in plasma when received as combination therapy [99]
    End point description
    CL/F was defined as the apparent oral clearance of INCB059872.
    End point type
    Secondary
    End point timeframe
    Cycle 1 Day 15: 0.5, 1, 2, 4, and 6 hours after INCB059872 dose
    Notes
    [99] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not performed for this endpoint.
    End point values
    		 Group C: Combination Therapy; INCB059872 2 mg QD + ATRA Group C: Combination Therapy; INCB059872 3 mg QD + ATRA Group C: Combination Therapy; INCB059872 4 mg QD + ATRA Group D: Combination Therapy; INCB059872 2 mg QD + azacitidine Group D: Combination Therapy; INCB059872 3 mg QD + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Number of subjects analysed
    4
    2
    0 [100]
    3
    0 [101]
    5
    Units: Liters per hour
        arithmetic mean (standard deviation)
    25.1 ( 7.21 )
    20.7 ( 1.41 )
    ( )
    19.0 ( 1.70 )
    ( )
    23.5 ( 8.14 )
    Notes
    [100] - No participants contributed to the analysis.
    [101] - No participants contributed to the analysis.
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    up to 1387 days
    Adverse event reporting additional 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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Group A: INCB059872 Monotherapy; AML or MDS
    Reporting group description
    		 Group A: Participants with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) received oral INB059872 2 milligrams (mg) or 3 mg as monotherapy once every other day (QOD) or 2 mg, 3mg, 4 mg, or 5 mg as monotherapy once daily (QD) on a 28-day continuous therapy cycle.

    Reporting group title
    Group B: INCB059872 Monotherapy; SCLC/solid malignancies
    Reporting group description
    		 Participants with small cell lung cancer (SCLC) and other solid malignancies (e.g., endocrine tumors) received oral INB059872 1 mg, 2 mg, or 3 mg as monotherapy QD or 2 mg, 3 mg, or 4 mg as monotherapy QOD on a 28-day continuous therapy cycle.

    Reporting group title
    Total
    Reporting group description
    		 Total

    Reporting group title
    Group D: Combination Therapy; INCB059872 + azacitidine
    Reporting group description
    		 Participants with newly diagnosed, treatment-naïve AML or MDS received INCB059872 2 mg or 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.

    Reporting group title
    Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab
    Reporting group description
    		 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.

    Reporting group title
    Group C: Combination Therapy; INCB059872 + ATRA
    Reporting group description
    		 Participants with relapsed/refractory AML received oral INCB059872 2 mg, 3 mg, or 4 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.

    Serious adverse events
    		 Group A: INCB059872 Monotherapy; AML or MDS Group B: INCB059872 Monotherapy; SCLC/solid malignancies Total Group D: Combination Therapy; INCB059872 + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab Group C: Combination Therapy; INCB059872 + ATRA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 35 (60.00%)
    33 / 53 (62.26%)
    71 / 115 (61.74%)
    7 / 8 (87.50%)
    2 / 6 (33.33%)
    8 / 13 (61.54%)
         number of deaths (all causes)
    28
    40
    87
    4
    3
    12
         number of deaths resulting from adverse events
    7
    6
    16
    0
    1
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Blast cell crisis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 53 (5.66%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 53 (3.77%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenic syndrome
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    10 / 35 (28.57%)
    1 / 53 (1.89%)
    17 / 115 (14.78%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    5 / 13 (38.46%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 1
    1 / 23
    0 / 1
    0 / 0
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 53 (0.00%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    Thrombocytopenia
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 53 (1.89%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
    3 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 35 (0.00%)
    4 / 53 (7.55%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 2
    2 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Swollen tongue
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 53 (3.77%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    1 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acute febrile neutrophilic dermatosis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Pneumonia
         subjects affected / exposed
    4 / 35 (11.43%)
    3 / 53 (5.66%)
    9 / 115 (7.83%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 9
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Failure to thrive
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group A: INCB059872 Monotherapy; AML or MDS Group B: INCB059872 Monotherapy; SCLC/solid malignancies Total Group D: Combination Therapy; INCB059872 + azacitidine Group E: Combination Therapy; INCB059872 3 mg QOD + nivolumab Group C: Combination Therapy; INCB059872 + ATRA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 35 (97.14%)
    51 / 53 (96.23%)
    111 / 115 (96.52%)
    8 / 8 (100.00%)
    6 / 6 (100.00%)
    12 / 13 (92.31%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    Hypotension
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 53 (1.89%)
    5 / 115 (4.35%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    1
    5
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    4
    0
    0
    0
    Chest pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Chills
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Fatigue
         subjects affected / exposed
    12 / 35 (34.29%)
    27 / 53 (50.94%)
    50 / 115 (43.48%)
    3 / 8 (37.50%)
    5 / 6 (83.33%)
    3 / 13 (23.08%)
         occurrences all number
    12
    31
    55
    3
    6
    3
    Influenza like illness
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    2
    2
    0
    0
    Injection site erythema
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    4
    4
    0
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 53 (5.66%)
    9 / 115 (7.83%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    4
    3
    10
    1
    0
    2
    Oedema
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 53 (0.00%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    4
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 53 (3.77%)
    4 / 115 (3.48%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    2
    4
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 53 (5.66%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    3
    4
    0
    0
    0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 35 (11.43%)
    6 / 53 (11.32%)
    13 / 115 (11.30%)
    1 / 8 (12.50%)
    2 / 6 (33.33%)
    0 / 13 (0.00%)
         occurrences all number
    4
    6
    15
    1
    4
    0
    Dyspnoea
         subjects affected / exposed
    4 / 35 (11.43%)
    8 / 53 (15.09%)
    14 / 115 (12.17%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    4
    8
    14
    1
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 53 (3.77%)
    9 / 115 (7.83%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    1
    3
    11
    3
    0
    4
    Hiccups
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 53 (5.66%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    3
    3
    0
    0
    0
    Hypoxia
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    3
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    3
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Pulmonary oedema
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    3
    0
    0
    0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Pleural effusion
         subjects affected / exposed
    3 / 35 (8.57%)
    1 / 53 (1.89%)
    6 / 115 (5.22%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    1
    6
    1
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 53 (5.66%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    3
    3
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 35 (2.86%)
    5 / 53 (9.43%)
    8 / 115 (6.96%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    5
    8
    1
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 35 (2.86%)
    2 / 53 (3.77%)
    5 / 115 (4.35%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    2
    5
    1
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 35 (0.00%)
    5 / 53 (9.43%)
    6 / 115 (5.22%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    6
    7
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    3
    0
    0
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 53 (7.55%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    4
    6
    0
    0
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 53 (5.66%)
    5 / 115 (4.35%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    4
    6
    2
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 53 (5.66%)
    7 / 115 (6.09%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    3
    8
    2
    0
    0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Lymphocyte count decreased
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 53 (3.77%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    3
    3
    7
    0
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    2 / 35 (5.71%)
    6 / 53 (11.32%)
    11 / 115 (9.57%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    2
    8
    13
    1
    1
    1
    Platelet count decreased
         subjects affected / exposed
    5 / 35 (14.29%)
    13 / 53 (24.53%)
    22 / 115 (19.13%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    2 / 13 (15.38%)
         occurrences all number
    5
    16
    27
    1
    3
    2
    Troponin increased
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    5 / 35 (14.29%)
    5 / 53 (9.43%)
    14 / 115 (12.17%)
    2 / 8 (25.00%)
    2 / 6 (33.33%)
    0 / 13 (0.00%)
         occurrences all number
    5
    5
    14
    2
    2
    0
    White blood cell count decreased
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 53 (7.55%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    6
    8
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    4 / 115 (3.48%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    4
    1
    0
    0
    Fall
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 53 (7.55%)
    8 / 115 (6.96%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    4
    8
    1
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Transfusion reaction
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    3
    2
    0
    0
    Cardiac disorders
    Atrial enlargement
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    1 / 35 (2.86%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    1
    3
    1
    0
    0
    Pericardial effusion
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    Sinus tachycardia
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    1
    4
    0
    1
    0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Tachycardia
         subjects affected / exposed
    3 / 35 (8.57%)
    0 / 53 (0.00%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    3
    0
    0
    0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Dizziness
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 53 (5.66%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    3
    6
    0
    0
    0
    Dysgeusia
         subjects affected / exposed
    6 / 35 (17.14%)
    10 / 53 (18.87%)
    20 / 115 (17.39%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    6
    10
    20
    2
    0
    2
    Headache
         subjects affected / exposed
    6 / 35 (17.14%)
    1 / 53 (1.89%)
    12 / 115 (10.43%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    6
    1
    13
    2
    0
    4
    Neuropathy peripheral
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Somnolence
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Taste disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    5 / 53 (9.43%)
    5 / 115 (4.35%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    5
    5
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 35 (31.43%)
    6 / 53 (11.32%)
    20 / 115 (17.39%)
    0 / 8 (0.00%)
    2 / 6 (33.33%)
    1 / 13 (7.69%)
         occurrences all number
    11
    7
    21
    0
    2
    1
    Febrile neutropenia
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 53 (0.00%)
    5 / 115 (4.35%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    4
    0
    7
    3
    0
    0
    Leukopenia
         subjects affected / exposed
    3 / 35 (8.57%)
    2 / 53 (3.77%)
    6 / 115 (5.22%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    3
    7
    1
    0
    0
    Lymph node pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Neutropenia
         subjects affected / exposed
    5 / 35 (14.29%)
    7 / 53 (13.21%)
    13 / 115 (11.30%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    5
    8
    14
    0
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    7 / 35 (20.00%)
    14 / 53 (26.42%)
    30 / 115 (26.09%)
    5 / 8 (62.50%)
    3 / 6 (50.00%)
    1 / 13 (7.69%)
         occurrences all number
    10
    19
    49
    12
    6
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Hypoacusis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    0
    1
    1
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    Eye inflammation
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Eye irritation
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    Vitreous floaters
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    3
    5
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    2 / 35 (5.71%)
    7 / 53 (13.21%)
    10 / 115 (8.70%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    7
    10
    0
    1
    0
    Constipation
         subjects affected / exposed
    5 / 35 (14.29%)
    11 / 53 (20.75%)
    23 / 115 (20.00%)
    5 / 8 (62.50%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    5
    13
    25
    5
    1
    1
    Diarrhoea
         subjects affected / exposed
    7 / 35 (20.00%)
    9 / 53 (16.98%)
    20 / 115 (17.39%)
    1 / 8 (12.50%)
    2 / 6 (33.33%)
    1 / 13 (7.69%)
         occurrences all number
    7
    10
    21
    1
    2
    1
    Dyspepsia
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    Dysphagia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    3
    0
    1
    0
    Dry mouth
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    7 / 115 (6.09%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    2
    7
    2
    0
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Gingival hypertrophy
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Lip dry
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Mouth haemorrhage
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    1
    0
    3
    0
    0
    2
    Nausea
         subjects affected / exposed
    11 / 35 (31.43%)
    14 / 53 (26.42%)
    31 / 115 (26.96%)
    3 / 8 (37.50%)
    1 / 6 (16.67%)
    2 / 13 (15.38%)
         occurrences all number
    11
    15
    34
    5
    1
    2
    Oesophagitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Oral blood blister
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    1
    0
    1
    Oral disorder
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    Paraesthesia oral
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    2 / 35 (5.71%)
    4 / 53 (7.55%)
    11 / 115 (9.57%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    3 / 13 (23.08%)
         occurrences all number
    2
    4
    11
    1
    1
    3
    Vomiting
         subjects affected / exposed
    10 / 35 (28.57%)
    8 / 53 (15.09%)
    21 / 115 (18.26%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    11
    8
    24
    3
    1
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    2
    0
    0
    1
    Blister
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Dry skin
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    2
    1
    6
    0
    0
    3
    Ecchymosis
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    4 / 115 (3.48%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    2
    4
    0
    0
    0
    Nail disorder
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Petechiae
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    5 / 115 (4.35%)
    2 / 8 (25.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    3
    1
    6
    2
    0
    0
    Skin irritation
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    Rash pruritic
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    Rash
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 53 (1.89%)
    7 / 115 (6.09%)
    1 / 8 (12.50%)
    2 / 6 (33.33%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    7
    1
    2
    1
    Rash erythematous
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    2
    1
    1
    0
    Pruritus
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    4 / 115 (3.48%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    4
    1
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Skin ulcer
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Vitiligo
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    3
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 35 (20.00%)
    6 / 53 (11.32%)
    18 / 115 (15.65%)
    1 / 8 (12.50%)
    3 / 6 (50.00%)
    1 / 13 (7.69%)
         occurrences all number
    7
    6
    19
    1
    4
    1
    Arthritis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    2
    1
    0
    0
    Back pain
         subjects affected / exposed
    3 / 35 (8.57%)
    4 / 53 (7.55%)
    8 / 115 (6.96%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    3
    5
    9
    0
    1
    0
    Muscular weakness
         subjects affected / exposed
    1 / 35 (2.86%)
    4 / 53 (7.55%)
    5 / 115 (4.35%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    5
    6
    0
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 53 (3.77%)
    3 / 115 (2.61%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    2
    3
    0
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 35 (2.86%)
    3 / 53 (5.66%)
    8 / 115 (6.96%)
    0 / 8 (0.00%)
    2 / 6 (33.33%)
    2 / 13 (15.38%)
         occurrences all number
    1
    3
    8
    0
    2
    2
    Neck pain
         subjects affected / exposed
    2 / 35 (5.71%)
    2 / 53 (3.77%)
    6 / 115 (5.22%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    2
    2
    6
    1
    0
    1
    Pain in jaw
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Pain in extremity
         subjects affected / exposed
    4 / 35 (11.43%)
    0 / 53 (0.00%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    4
    0
    6
    0
    1
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 35 (0.00%)
    1 / 53 (1.89%)
    3 / 115 (2.61%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    4
    1
    2
    0
    Catheter site cellulitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Gingivitis
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    2
    1
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Nail infection
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Onychomycosis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    0
    0
    2
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    0 / 35 (0.00%)
    0 / 53 (0.00%)
    1 / 115 (0.87%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 35 (28.57%)
    10 / 53 (18.87%)
    25 / 115 (21.74%)
    2 / 8 (25.00%)
    3 / 6 (50.00%)
    0 / 13 (0.00%)
         occurrences all number
    10
    10
    25
    2
    3
    0
    Hypocalcaemia
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 53 (0.00%)
    2 / 115 (1.74%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    2
    0
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 53 (1.89%)
    6 / 115 (5.22%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    5
    1
    7
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 35 (2.86%)
    5 / 53 (9.43%)
    7 / 115 (6.09%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    1
    5
    7
    1
    0
    0
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 35 (8.57%)
    3 / 53 (5.66%)
    8 / 115 (6.96%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    3
    3
    8
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    5 / 35 (14.29%)
    3 / 53 (5.66%)
    9 / 115 (7.83%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    0 / 13 (0.00%)
         occurrences all number
    5
    3
    9
    1
    0
    0
    Hypomagnesaemia
         subjects affected / exposed
    4 / 35 (11.43%)
    1 / 53 (1.89%)
    6 / 115 (5.22%)
    0 / 8 (0.00%)
    1 / 6 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    4
    2
    7
    0
    1
    0
    Hyponatraemia
         subjects affected / exposed
    4 / 35 (11.43%)
    5 / 53 (9.43%)
    12 / 115 (10.43%)
    1 / 8 (12.50%)
    1 / 6 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    4
    5
    13
    1
    1
    2
    Hypophosphataemia
         subjects affected / exposed
    4 / 35 (11.43%)
    5 / 53 (9.43%)
    11 / 115 (9.57%)
    1 / 8 (12.50%)
    0 / 6 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    4
    7
    15
    3
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jan 2016
    The primary purpose of Amendment 1 was to delete combination therapy from the study design, refine exclusion criteria, add to the prohibited medication list, increase dose-limiting toxicity language, improve language for restarting study drug and at what increments, and add stopping rules.
    28 Jul 2016
    The primary purpose of this amendment was to update the language in the inclusion and exclusion criteria to provide more clarity, to provide additional language regarding different regimens to be explored in this study, and to update Tables 1 through 5.
    22 Sep 2017
    The primary purpose of this amendment was to add dose-finding and expansion cohorts to evaluate INCB059872 in combination with select conventional care treatment regimens in participants with select advanced malignancies and to update aspects of the monotherapy design based on emerging data from the current study.
    06 Nov 2017
    The primary purpose of this amendment was to update the selected doses for monotherapy expansion in Part 2, update the starting doses of INCB059872 in Part 3, clarify dose-limiting toxicity (DLT) evaluability criteria, add early stopping rules for futility in Part 4, adjust the endpoints, revise the eligibility criteria for Cohorts D and D1, add an internal safety committee, and remove references to a pharmacologically active dose.
    30 Jul 2018
    The primary purpose of this amendment was to update and add treatment modification guidance for serious adverse events (SAEs) with suspected causal relationship to study drug.
    16 Apr 2019
    The primary purpose of this amendment was to update Treatment Group D to include myelodysplastic syndrome (MDS) participants, update dose interruption and modification guidance, update inclusion criteria, and update the schedule of assessments for myelofibrosis (MF) participants.
    13 Jun 2019
    The primary purpose of this amendment was to include additional safety monitoring and modify the inclusion criteria for MDS participants in Treatment Group D for Parts 3 and 4 of the Protocol.
    15 Jun 2020
    The primary purpose of this amendment was to add a principal coordinating investigator and remove the exploratory endpoint of overall survival.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated by the sponsor due to a strategic business decision.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 07 00:13:11 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA