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    Clinical Trial Results:
    A Phase 2, Open-Label, 2-Cohort Study of INCB050465, a PI3Kδ Inhibitor, in Subjects With Relapsed or Refractory Marginal Zone Lymphoma With or Without Prior Exposure to a BTK Inhibitor

    Summary
    EudraCT number
    		 2017-000970-12
    Trial protocol
    		 GB   ES   DE   BE   DK   FR   PL   IT  
    Global end of trial date
    29 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jun 2025
    First version publication date
    05 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 50465-204 (CITADEL-204)
    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
    29 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study was conducted to assess the efficacy of INCB050465 in terms of objective response rate (ORR) in participants with marginal zone lymphoma that is relapsed or refractory after at least 1 systemic treatment regimen.
    Protection of trial subjects
    This study was 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 on Harmonisation Good Clinical Practice consolidated guidelines (E6) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 1
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    Israel: 12
    Country: Number of subjects enrolled
    Italy: 25
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    110
    EEA total number of subjects
    53
    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)
    28
    From 65 to 84 years
    73
    85 years and over
    9

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study enrolled participants at 46 study centers in the United States, Italy, Israel, France, Spain, Poland, Belgium, Great Britain, and Germany.

    Pre-assignment
    Screening details
    		 110 participants with relapsed or refractory marginal zone lymphoma were enrolled based on previous treatment with ibrutinib as Cohort 1 (exposed to ibrutinib before enrollment) and Cohort 2 (not exposed to Bruton’s tyrosine kinase [BTK] inhibitor before enrollment). Participants were further allocated to Treatments A and B in each Cohort.

    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
    		 Cohort 1: Treatment A (Exposed to Ibrutinib)
    Arm description
    		 Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg, 2.5 mg, 5 mg, and 20 mg tablets taken orally

    Arm title
    		 Cohort 1: Treatment B (Exposed to Ibrutinib)
    Arm description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg, 2.5 mg, 5 mg, and 20 mg tablets taken orally

    Arm title
    		 Cohort 2: Treatment A (BTK Inhibitor Naïve)
    Arm description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW, for up to 52 weeks. Participants who were not exposed to Bruton's Tyrosine Kinase (BTK) inhibitor before enrollment were included in this group
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg, 2.5 mg, 5 mg, and 20 mg tablets taken orally

    Arm title
    		 Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Arm description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    parsaclisib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    1 mg, 2.5 mg, 5 mg, and 20 mg tablets taken orally

    Number of subjects in period 1
    		Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Started
    4
    6
    28
    72
    Completed
    0
    2
    13
    26
    Not completed
    4
    4
    15
    46
         Adverse event, serious fatal
    3
    2
    6
    24
         Changed Physicians
    -
    -
    -
    1
         Exclusion Criteria Met
    -
    -
    1
    -
         Withdrawal by Participant
    -
    -
    2
    6
         Site Closed
    -
    -
    -
    1
         Histological Criteria Not Met
    -
    -
    -
    1
         Participant Transferred to Rollover Study
    1
    1
    5
    6
         Removed for Safety
    -
    -
    -
    1
         Progression of Chronic Lymphocytic Leukemia
    -
    -
    -
    1
         Lost to follow-up
    -
    1
    -
    4
         Discharged from the Trust
    -
    -
    1
    -
         Multifactorial Cognitive Decline
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: Treatment A (Exposed to Ibrutinib)
    Reporting group description
    		 Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

    Reporting group title
    Cohort 1: Treatment B (Exposed to Ibrutinib)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

    Reporting group title
    Cohort 2: Treatment A (BTK Inhibitor Naïve)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW, for up to 52 weeks. Participants who were not exposed to Bruton's Tyrosine Kinase (BTK) inhibitor before enrollment were included in this group

    Reporting group title
    Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.

    Reporting group values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve) Total
    Number of subjects
    		 4 6 28 72 110
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 0 0 8 20 28
        From 65-84 years
    		 4 6 19 44 73
        85 years and over
    		 0 0 1 8 9
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 73.5 (71 to 76) 72.2 (65 to 78) 68.1 (52 to 86) 69.8 (35 to 95) -
    Sex: Female, Male
    Units: participants
        Female
    		 2 4 16 31 53
        Male
    		 2 2 12 41 57
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 2 3 4 9
        Not Hispanic or Latino
    		 3 4 19 57 83
        Unknown or Not Reported
    		 1 0 6 11 18
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 0 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 1 0 1 2
        White
    		 3 5 23 60 91
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 1 0 5 10 16

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: Treatment A (Exposed to Ibrutinib)
    Reporting group description
    		 Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

    Reporting group title
    Cohort 1: Treatment B (Exposed to Ibrutinib)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

    Reporting group title
    Cohort 2: Treatment A (BTK Inhibitor Naïve)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 20 mg QW, for up to 52 weeks. Participants who were not exposed to Bruton's Tyrosine Kinase (BTK) inhibitor before enrollment were included in this group

    Reporting group title
    Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.

    Primary: Objective Response Rate (ORR) Based on Lugano Classification Criteria

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    End point title
    		 Objective Response Rate (ORR) Based on Lugano Classification Criteria [1]
    End point description
    ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign 5mm×5mm as default;if no longer visible,0×0mm.Node >5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by >50%in length beyond normal.4.No new lesions.
    End point type
    Primary
    End point timeframe
    Up to approximately 161 weeks
    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 conducted for this endpoint.
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    4 [2]
    6 [3]
    28 [4]
    72 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    50.0 (6.8 to 93.2)
    33.3 (4.3 to 77.7)
    57.1 (37.2 to 75.5)
    58.3 (46.1 to 69.8)
    Notes
    [2] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [3] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [4] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [5] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    No statistical analyses for this end point

    Secondary: Complete Response Rate (CRR) based on Lugano Classification Criteria

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    End point title
    		 Complete Response Rate (CRR) based on Lugano Classification Criteria
    End point description
    CRR is defined as the percentage of participants with a CR as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
    End point type
    Secondary
    End point timeframe
    Up to 1305 days
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    4 [6]
    6 [7]
    28 [8]
    72 [9]
    Units: percentage of participants
        number (confidence interval 95%)
    0.0 (0.0 to 60.2)
    0.0 (0.0 to 45.9)
    10.7 (2.3 to 28.2)
    4.2 (0.9 to 11.7)
    Notes
    [6] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [7] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [8] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [9] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR=time from first documented evidence of CR/PR until disease progression/death from any cause among participants who achieve an objective response as determined by IRC. CR: 1.Target nodes/nodal masses of lymph nodes/extralymphatic sites must regress to ≤1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow normal by morphology; if indeterminate, immunohistochemistry negative. PR: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen regressed by >50% in length beyond normal. 4.No new lesions. -9999, 9999=not estimable due to the low number of participants with events of response.
    End point type
    Secondary
    End point timeframe
    Up to 1305 days
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    2 [10]
    2 [11]
    17 [12]
    41 [13]
    Units: months
        median (confidence interval 95%)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    16.69 (3.71 to 9999)
    13.57 (8.05 to 17.74)
    Notes
    [10] - Full Analysis Set. Only participants with objective response were analyzed.
    [11] - Full Analysis Set. Only participants with objective response were analyzed.
    [12] - Full Analysis Set. Only participants with objective response were analyzed.
    [13] - Full Analysis Set. Only participants with objective response were analyzed.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    OS is defined as the time from the date of the first dose of study treatment until death from any cause. 9999=values were not estimable due to the low number of participants with events.
    End point type
    Secondary
    End point timeframe
    up to 2354 days
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    4 [14]
    6 [15]
    28 [16]
    72 [17]
    Units: months
        median (confidence interval 95%)
    18.94 (7.26 to 9999)
    9999 (3.22 to 9999)
    9999 (59.60 to 9999)
    63.54 (39.72 to 9999)
    Notes
    [14] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [15] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [16] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [17] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    No statistical analyses for this end point

    Secondary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause. -9999, 9999=The median and the lower and upper limits of the 95% CI were not estimable due to the low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Up to 1305 days
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    4 [18]
    6 [19]
    28 [20]
    72 [21]
    Units: months
        median (confidence interval 95%)
    9999 (-9999 to 9999)
    9999 (-9999 to 9999)
    19.42 (8.77 to 9999)
    17.74 (11.53 to 22.34)
    Notes
    [18] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [19] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [20] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [21] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    No statistical analyses for this end point

    Secondary: Best Percent Change from Baseline in Target Lesion Size

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    End point title
    		 Best Percent Change from Baseline in Target Lesion Size
    End point description
    Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Up to 1305 days
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    4 [22]
    5 [23]
    20 [24]
    51 [25]
    Units: percent change in lesion size
        arithmetic mean (standard deviation)
    -48.83 ( 21.193 )
    -54.84 ( 21.454 )
    -71.22 ( 18.566 )
    -66.76 ( 19.971 )
    Notes
    [22] - Full Analysis Set. Only participants with available data were analyzed.
    [23] - Full Analysis Set. Only participants with available data were analyzed.
    [24] - Full Analysis Set. Only participants with available data were analyzed.
    [25] - Full Analysis Set. Only participants with available data were analyzed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to 1980 days
    End point values
    		 Cohort 1: Treatment A (Exposed to Ibrutinib) Cohort 1: Treatment B (Exposed to Ibrutinib) Cohort 2: Treatment A (BTK Inhibitor Naïve) Cohort 2: Treatment B (BTK Inhibitor Naïve)
    Number of subjects analysed
    4 [26]
    6 [27]
    28 [28]
    72 [29]
    Units: percentage of participants
    number (not applicable)
        TEAEs
    100.0
    83.3
    92.9
    97.2
        SAEs
    50.0
    33.3
    32.1
    63.9
    Notes
    [26] - Safety Population: all enrolled participants who received at least 1 dose of parsaclisib
    [27] - Safety Population: all enrolled participants who received at least 1 dose of parsaclisib
    [28] - Safety Population: all enrolled participants who received at least 1 dose of parsaclisib
    [29] - Safety Population: all enrolled participants who received at least 1 dose of parsaclisib
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 2354 days
    Adverse event reporting additional description
    Adverse events have been reported for members of the Safety Population, comprised of all enrolled participants who received at least 1 dose of parsaclisib.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Cohort 1: Treatment (Trt) A (Exposed to Ibrutinib)
    Reporting group description
    		 Participants received parsaclisib 20 milligrams (mg), orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW), for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

    Reporting group title
    Cohort 2: Trt B (Bruton's Tyrosine Kinase Inhibitor Naïve)
    Reporting group description
    		 Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg tablets QD, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.

    Reporting group title
    Cohort 2: Trt A (Bruton's Tyrosine Kinase Inhibitor Naïve)
    Reporting group description
    		 Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg tablets QW, for up to 52 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.

    Reporting group title
    Cohort 1: Treatment B (Exposed to Ibrutinib)
    Reporting group description
    		 Participants received parsaclisib 20 mg, orally, QD for 8 weeks followed by 2.5 mg QD, for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

    Serious adverse events
    		 Cohort 1: Treatment (Trt) A (Exposed to Ibrutinib) Cohort 2: Trt B (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Trt A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 1: Treatment B (Exposed to Ibrutinib)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 4 (50.00%)
    46 / 72 (63.89%)
    9 / 28 (32.14%)
    2 / 6 (33.33%)
         number of deaths (all causes)
    3
    25
    6
    2
         number of deaths resulting from adverse events
    0
    8
    2
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen's disease
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Marginal zone lymphoma recurrent
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pain
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Mental status changes
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Investigations
    Blood calcium increased
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecal volume increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eosinophilia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 5
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Hyperviscosity syndrome
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microangiopathic haemolytic anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Retinal haemorrhage
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 6
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Oliguria
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection reactivation
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 4 (25.00%)
    7 / 72 (9.72%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    4 / 8
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Yersinia infection
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    2 / 6 (33.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: Treatment (Trt) A (Exposed to Ibrutinib) Cohort 2: Trt B (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 2: Trt A (Bruton's Tyrosine Kinase Inhibitor Naïve) Cohort 1: Treatment B (Exposed to Ibrutinib)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 4 (100.00%)
    67 / 72 (93.06%)
    25 / 28 (89.29%)
    5 / 6 (83.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 72 (6.94%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    5
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    2
    0
    Hypotension
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    4 / 28 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    6
    0
    Chest pain
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 4 (25.00%)
    11 / 72 (15.28%)
    3 / 28 (10.71%)
    1 / 6 (16.67%)
         occurrences all number
    1
    11
    5
    1
    Influenza like illness
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 72 (12.50%)
    3 / 28 (10.71%)
    1 / 6 (16.67%)
         occurrences all number
    0
    9
    3
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 4 (0.00%)
    10 / 72 (13.89%)
    4 / 28 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    0
    14
    8
    2
    Reproductive system and breast disorders
    Vulvovaginal dryness
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 4 (25.00%)
    7 / 72 (9.72%)
    2 / 28 (7.14%)
    1 / 6 (16.67%)
         occurrences all number
    1
    7
    2
    1
    Cough
         subjects affected / exposed
    0 / 4 (0.00%)
    22 / 72 (30.56%)
    5 / 28 (17.86%)
    2 / 6 (33.33%)
         occurrences all number
    0
    24
    8
    3
    Epistaxis
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 72 (4.17%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    3
    3
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    2 / 28 (7.14%)
    1 / 6 (16.67%)
         occurrences all number
    0
    4
    3
    1
    Productive cough
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    7
    1
    0
    Pulmonary embolism
         subjects affected / exposed
    2 / 4 (50.00%)
    1 / 72 (1.39%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Insomnia
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    1
    0
    Investigations
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 72 (2.78%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    5
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    7 / 72 (9.72%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    11
    5
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    9
    6
    0
    Platelet count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    11
    2
    0
    Neutrophil count decreased
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    2 / 28 (7.14%)
    1 / 6 (16.67%)
         occurrences all number
    0
    9
    7
    2
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 72 (4.17%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 72 (4.17%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    1
    9
    3
    0
    Chest injury
         subjects affected / exposed
    1 / 4 (25.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 72 (12.50%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    11
    2
    0
    Headache
         subjects affected / exposed
    0 / 4 (0.00%)
    10 / 72 (13.89%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    0
    12
    3
    0
    Syncope
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Paraesthesia
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    10 / 72 (13.89%)
    4 / 28 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    14
    5
    0
    Neutropenia
         subjects affected / exposed
    0 / 4 (0.00%)
    10 / 72 (13.89%)
    4 / 28 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    0
    20
    5
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    4
    0
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vision blurred
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 4 (50.00%)
    10 / 72 (13.89%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    2
    11
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    3
    0
    Dyspepsia
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    3
    0
    Dry mouth
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    2 / 28 (7.14%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    2
    1
    Diarrhoea
         subjects affected / exposed
    1 / 4 (25.00%)
    37 / 72 (51.39%)
    9 / 28 (32.14%)
    2 / 6 (33.33%)
         occurrences all number
    1
    66
    19
    3
    Constipation
         subjects affected / exposed
    1 / 4 (25.00%)
    11 / 72 (15.28%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    1
    12
    5
    0
    Colitis
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 72 (6.94%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    2 / 28 (7.14%)
    1 / 6 (16.67%)
         occurrences all number
    0
    4
    2
    1
    Nausea
         subjects affected / exposed
    1 / 4 (25.00%)
    13 / 72 (18.06%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    1
    18
    3
    0
    Stomatitis
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 72 (6.94%)
    4 / 28 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    5
    6
    0
    Vomiting
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 72 (6.94%)
    4 / 28 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    8
    5
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 4 (25.00%)
    2 / 72 (2.78%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Actinic keratosis
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    4
    0
    Ecchymosis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Dry skin
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 72 (6.94%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    5
    2
    0
    Eczema
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    3 / 28 (10.71%)
    0 / 6 (0.00%)
         occurrences all number
    0
    5
    3
    0
    Erythema
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 4 (0.00%)
    11 / 72 (15.28%)
    5 / 28 (17.86%)
    1 / 6 (16.67%)
         occurrences all number
    0
    13
    6
    1
    Rash
         subjects affected / exposed
    1 / 4 (25.00%)
    11 / 72 (15.28%)
    5 / 28 (17.86%)
    1 / 6 (16.67%)
         occurrences all number
    1
    12
    8
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 4 (0.00%)
    5 / 72 (6.94%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    3
    0
    Rash pruritic
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    3
    2
    0
    Rosacea
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    1
    0
    Arthralgia
         subjects affected / exposed
    0 / 4 (0.00%)
    9 / 72 (12.50%)
    4 / 28 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    0
    11
    4
    1
    Muscle spasms
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    4
    0
    Myalgia
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    2 / 28 (7.14%)
    1 / 6 (16.67%)
         occurrences all number
    0
    4
    3
    1
    Neck pain
         subjects affected / exposed
    0 / 4 (0.00%)
    2 / 72 (2.78%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    1
    1
    Muscular weakness
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 4 (25.00%)
    4 / 72 (5.56%)
    4 / 28 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    2
    4
    4
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Herpes zoster
         subjects affected / exposed
    0 / 4 (0.00%)
    3 / 72 (4.17%)
    1 / 28 (3.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    3
    1
    1
    Infected bite
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 72 (4.17%)
    4 / 28 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    1
    3
    4
    1
    Sinusitis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 4 (25.00%)
    11 / 72 (15.28%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    13
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    3 / 28 (10.71%)
    1 / 6 (16.67%)
         occurrences all number
    0
    9
    3
    1
    Rhinitis
         subjects affected / exposed
    1 / 4 (25.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 4 (25.00%)
    3 / 72 (4.17%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 4 (0.00%)
    1 / 72 (1.39%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    0
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    0
    0
    Decreased appetite
         subjects affected / exposed
    1 / 4 (25.00%)
    11 / 72 (15.28%)
    2 / 28 (7.14%)
    0 / 6 (0.00%)
         occurrences all number
    1
    12
    3
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    5
    0
    2
    Hyperkalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    6 / 72 (8.33%)
    1 / 28 (3.57%)
    0 / 6 (0.00%)
         occurrences all number
    0
    8
    1
    0
    Hypokalaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    4 / 72 (5.56%)
    0 / 28 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    11
    0
    0
    Hypoglycaemia
         subjects affected / exposed
    0 / 4 (0.00%)
    0 / 72 (0.00%)
    0 / 28 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jul 2018
    The primary purpose of this amendment was to modify the dose reduction schedules.
    07 Dec 2018
    The primary purpose of this amendment was to close enrollment in Cohort 1 and to increase the number of participants enrolled in Cohort 2 to better understand the safety and efficacy of INCB050465 administered at one of the 2 treatment regimens.
    20 Dec 2019
    The primary purpose of this amendment was to provide additional guidance on dose modification in the event of diarrhea and colitis and to define the end of the study, including the option to receive continued treatment with INCB050465 in a rollover protocol.
    07 Sep 2022
    The primary purpose of this amendment was to describe risks associated with COVID-19.
    24 Jan 2024
    The primary purpose of this amendment was to institute hematology testing every 2 weeks for the first 8 weeks of dosing and revise the exclusion criterion for liver disease.

    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.
    None reported
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    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.

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