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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Follicular Lymphoma

    Summary
    EudraCT number
    		 2017-001624-22
    Trial protocol
    		 GB   CZ   DK   SE   DE   HU   ES   IT  
    Global end of trial date
    07 Jun 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Mar 2025
    First version publication date
    26 Feb 2025
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Revisions made to align with updated ClinicalTrials.gov summary.

    Trial information

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    Trial identification
    Sponsor protocol code
    INCB 50465-203 (CITADEL-203)
    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
    07 Jun 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jun 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 relapsed or refractory follicular lymphoma (FL).
    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
    14 Mar 2018
    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
    Canada: 1
    Country: Number of subjects enrolled
    Czechia: 17
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    Spain: 18
    Country: Number of subjects enrolled
    United Kingdom: 17
    Country: Number of subjects enrolled
    Hungary: 4
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    Italy: 15
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United States: 29
    Worldwide total number of subjects
    126
    EEA total number of subjects
    69
    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)
    50
    From 65 to 84 years
    72
    85 years and over
    4

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 44 investigative sites in the United States, Italy, Spain, Great Britain, Czech Republic, Hungary, Canada, Denmark, Germany, Israel, Poland, and Sweden

    Pre-assignment
    Screening details
    		 A total of 126 participants with relapsed or refractory follicular lymphoma were enrolled in the study and assigned to one of two treatment groups: Treatment A or Treatment B to receive parsaclisib.

    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
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW
    Arm description
    		 Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.
    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
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Arm description
    		 Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.
    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
    		Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Started
    23
    103
    Completed
    14
    50
    Not completed
    9
    53
         Consent withdrawn by subject
    1
    9
         Physician decision
    1
    -
         Site Closed
    -
    1
         Death
    5
    27
         Did Not Return to Site for Care
    -
    1
         Lost to follow-up
    2
    4
         Transitioned to Rollover Study
    -
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW
    Reporting group description
    		 Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

    Reporting group title
    Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Reporting group description
    		 Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

    Reporting group values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD Total
    Number of subjects
    		 23 103 126
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 11 39 50
        From 65-84 years
    		 12 60 72
        85 years and over
    		 0 4 4
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.1 ( 11.56 ) 67.0 ( 10.68 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 11 45 56
        Male
    		 12 58 70
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 6 7
        Not Hispanic or Latino
    		 19 90 109
        Unknown or Not Reported
    		 3 7 10
    Race Customized
    Units: Subjects
        Asian
    		 0 1 1
        Black/ African- American
    		 1 6 7
        White/ Caucasian
    		 21 92 113
        Unavailable or Unknown
    		 1 4 5

    End points

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    End points reporting groups
    Reporting group title
    Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW
    Reporting group description
    		 Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

    Reporting group title
    Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Reporting group description
    		 Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

    Primary: Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

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    End point title
    		 Objective Response Rate With Parsaclisib Based on Lugano Classification Response 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),assign5mm×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 148 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
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    23 [2]
    103 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    65.2 (42.7 to 83.6)
    77.7 (68.4 to 85.3)
    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
    No statistical analyses for this end point

    Secondary: Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

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    End point title
    		 Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria
    End point description
    CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas 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 1193 days
    End point values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    23 [4]
    103 [5]
    Units: percentage of participants
        number (confidence interval 95%)
    17.4 (5.0 to 38.8)
    22.3 (14.7 to 31.6)
    Notes
    [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: Duration of Response (DOR)

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    End point title
    		 Duration of Response (DOR)
    End point description
    DOR=time from first documented CR or 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 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 normal by morphology; if indeterminate, immunohistochemistry negative. PR: 1.Lymph nodes/extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes/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=The upper limit of the CI was not estimable due to the low number of participants with events.
    End point type
    Secondary
    End point timeframe
    Up to 1193 days
    End point values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    15 [6]
    81 [7]
    Units: months
        median (confidence interval 95%)
    14.06 (3.19 to 9999)
    14.72 (11.76 to 25.72)
    Notes
    [6] - Only participants with an objective response were analyzed.
    [7] - Only participants with an objective response were analyzed.
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) With Parsaclisib

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    End point title
    		 Progression-free Survival (PFS) With Parsaclisib
    End point description
    PFS was 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.
    End point type
    Secondary
    End point timeframe
    Up to 1193 days
    End point values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    23 [8]
    103 [9]
    Units: months
        median (confidence interval 95%)
    19.32 (8.31 to 33.15)
    14.03 (11.07 to 20.07)
    Notes
    [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: Overall Survival (OS) With Parsaclisib

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    End point title
    		 Overall Survival (OS) With Parsaclisib
    End point description
    OS was defined as the time from the date of the first dose of study treatment until 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 1193 days
    End point values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    23 [10]
    103 [11]
    Units: months
        median (confidence interval 95%)
    9999 (35.48 to 9999)
    9999 (-9999 to 9999)
    Notes
    [10] - Full Analysis Set: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [11] - 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 non-missing 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 1193 days
    End point values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    20 [12]
    98 [13]
    Units: percent change in lesion size
        arithmetic mean (standard deviation)
    -72.90 ( 21.782 )
    -72.77 ( 31.972 )
    Notes
    [12] - Full Analysis Set. Only participants with available data were analyzed.
    [13] - 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 defined as 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. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or 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
    up to approximately 1992 days
    End point values
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Number of subjects analysed
    23 [14]
    103 [15]
    Units: percentage of participants
    number (not applicable)
        TEAEs
    100.0
    99.0
        SAEs
    52.2
    53.4
    Notes
    [14] - Safety Population: all participants enrolled in the study who received ≥1 dose of parsaclisib
    [15] - Safety Population: all participants enrolled in the study who received ≥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 approximately 1992 days
    Adverse event reporting additional description
    Adverse events have been reported for members of the Safety Population, comprised of all participants enrolled in the study 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
    Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD
    Reporting group description
    		 Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

    Reporting group title
    Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW
    Reporting group description
    		 Participants received parsaclisib 20 milligrams (mg) once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

    Serious adverse events
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW
    Total subjects affected by serious adverse events
         subjects affected / exposed
    55 / 103 (53.40%)
    12 / 23 (52.17%)
         number of deaths (all causes)
    27
    5
         number of deaths resulting from adverse events
    4
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder neoplasm
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Desmoplastic mesothelioma
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 103 (2.91%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 103 (2.91%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 103 (1.94%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body temperature increased
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 103 (1.94%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis erosive
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    8 / 103 (7.77%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    10 / 103 (9.71%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    9 / 11
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune-mediated enterocolitis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotid gland enlargement
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Rash
         subjects affected / exposed
    2 / 103 (1.94%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    3 / 103 (2.91%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune arthritis
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Campylobacter colitis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus colitis
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 103 (2.91%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 103 (1.94%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 103 (0.97%)
    2 / 23 (8.70%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 103 (0.00%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 103 (0.97%)
    1 / 23 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 103 (1.94%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 103 (0.97%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Parsaclisib 20 mg QD for 8 Weeks followed by 2.5 mg QD Parsaclisib 20 mg QD for 8 Weeks followed by 20 mg QW
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 103 (91.26%)
    22 / 23 (95.65%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Infected neoplasm
         subjects affected / exposed
    0 / 103 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    12 / 103 (11.65%)
    0 / 23 (0.00%)
         occurrences all number
    13
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    21 / 103 (20.39%)
    3 / 23 (13.04%)
         occurrences all number
    23
    3
    Asthenia
         subjects affected / exposed
    14 / 103 (13.59%)
    2 / 23 (8.70%)
         occurrences all number
    17
    2
    Oedema peripheral
         subjects affected / exposed
    10 / 103 (9.71%)
    1 / 23 (4.35%)
         occurrences all number
    10
    1
    Peripheral swelling
         subjects affected / exposed
    2 / 103 (1.94%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Pyrexia
         subjects affected / exposed
    20 / 103 (19.42%)
    2 / 23 (8.70%)
         occurrences all number
    26
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    28 / 103 (27.18%)
    3 / 23 (13.04%)
         occurrences all number
    30
    3
    Dyspnoea
         subjects affected / exposed
    8 / 103 (7.77%)
    0 / 23 (0.00%)
         occurrences all number
    10
    0
    Oropharyngeal pain
         subjects affected / exposed
    5 / 103 (4.85%)
    2 / 23 (8.70%)
         occurrences all number
    7
    2
    Wheezing
         subjects affected / exposed
    0 / 103 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 103 (5.83%)
    0 / 23 (0.00%)
         occurrences all number
    6
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    7 / 103 (6.80%)
    1 / 23 (4.35%)
         occurrences all number
    11
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 103 (1.94%)
    2 / 23 (8.70%)
         occurrences all number
    2
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 103 (7.77%)
    1 / 23 (4.35%)
         occurrences all number
    9
    1
    Weight decreased
         subjects affected / exposed
    6 / 103 (5.83%)
    0 / 23 (0.00%)
         occurrences all number
    6
    0
    Cardiac disorders
    Extrasystoles
         subjects affected / exposed
    0 / 103 (0.00%)
    2 / 23 (8.70%)
         occurrences all number
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    7 / 103 (6.80%)
    1 / 23 (4.35%)
         occurrences all number
    7
    1
    Headache
         subjects affected / exposed
    14 / 103 (13.59%)
    1 / 23 (4.35%)
         occurrences all number
    14
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 103 (6.80%)
    2 / 23 (8.70%)
         occurrences all number
    8
    2
    Neutropenia
         subjects affected / exposed
    16 / 103 (15.53%)
    2 / 23 (8.70%)
         occurrences all number
    21
    4
    Thrombocytopenia
         subjects affected / exposed
    7 / 103 (6.80%)
    1 / 23 (4.35%)
         occurrences all number
    7
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    9 / 103 (8.74%)
    0 / 23 (0.00%)
         occurrences all number
    12
    0
    Constipation
         subjects affected / exposed
    11 / 103 (10.68%)
    1 / 23 (4.35%)
         occurrences all number
    11
    1
    Diarrhoea
         subjects affected / exposed
    45 / 103 (43.69%)
    3 / 23 (13.04%)
         occurrences all number
    75
    5
    Nausea
         subjects affected / exposed
    28 / 103 (27.18%)
    8 / 23 (34.78%)
         occurrences all number
    34
    8
    Vomiting
         subjects affected / exposed
    9 / 103 (8.74%)
    3 / 23 (13.04%)
         occurrences all number
    10
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    3 / 103 (2.91%)
    4 / 23 (17.39%)
         occurrences all number
    5
    6
    Rash maculo-papular
         subjects affected / exposed
    7 / 103 (6.80%)
    1 / 23 (4.35%)
         occurrences all number
    7
    1
    Rash
         subjects affected / exposed
    15 / 103 (14.56%)
    6 / 23 (26.09%)
         occurrences all number
    18
    8
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    16 / 103 (15.53%)
    2 / 23 (8.70%)
         occurrences all number
    17
    2
    Back pain
         subjects affected / exposed
    9 / 103 (8.74%)
    1 / 23 (4.35%)
         occurrences all number
    9
    1
    Myalgia
         subjects affected / exposed
    5 / 103 (4.85%)
    2 / 23 (8.70%)
         occurrences all number
    5
    2
    Pain in extremity
         subjects affected / exposed
    8 / 103 (7.77%)
    1 / 23 (4.35%)
         occurrences all number
    8
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 103 (9.71%)
    1 / 23 (4.35%)
         occurrences all number
    12
    1
    Urinary tract infection
         subjects affected / exposed
    6 / 103 (5.83%)
    3 / 23 (13.04%)
         occurrences all number
    6
    3
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 103 (6.80%)
    3 / 23 (13.04%)
         occurrences all number
    8
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    12 / 103 (11.65%)
    2 / 23 (8.70%)
         occurrences all number
    13
    2
    Hyperglycaemia
         subjects affected / exposed
    7 / 103 (6.80%)
    2 / 23 (8.70%)
         occurrences all number
    8
    3
    Hypokalaemia
         subjects affected / exposed
    13 / 103 (12.62%)
    1 / 23 (4.35%)
         occurrences all number
    16
    1
    Hypomagnesaemia
         subjects affected / exposed
    10 / 103 (9.71%)
    0 / 23 (0.00%)
         occurrences all number
    12
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Mar 2017
    The primary purpose of this amendment was to align the visit schedule nomenclature with other CITADEL protocols.
    15 Aug 2017
    The primary purpose of this amendment was to address changes requested by the European Regulatory Agency.
    11 Sep 2017
    The primary purpose of this amendment was to address changes requested by the European Regulatory Agency.
    25 Oct 2017
    The primary purpose of this amendment was to remove the comparator arm (idelalisib) from the study.
    11 Jul 2018
    The primary purpose of this amendment was to modify the dose reduction schedules.
    04 Sep 2018
    The primary purpose of this amendment was to provide a list of CYP3A inhibitors and inducers.
    06 Dec 2018
    The primary purpose of the amendment was to stop the 1:1 allocation of participants after the 50th participant was enrolled and to enroll the remaining 50 participants to only 1 of the 2 treatment regimens being evaluated.
    23 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.

    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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