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    Clinical Trial Results:
    A Phase 2, Multicenter, Randomized Study of Trastuzumab Deruxtecan in Subjects with HER2-overexpressing Locally Advanced, Unresectable or Metastatic Colorectal Cancer (DESTINY-CRC02)

    Summary
    EudraCT number
    		 2020-004782-39
    Trial protocol
    		 FR   BE   IT   ES  
    Global end of trial date
    08 Oct 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Oct 2025
    First version publication date
    23 Feb 2024
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Study Completion has been achieved, results updated accordingly.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DS8201-A-U207
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04744831
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Daiichi Sankyo, Inc.
    Sponsor organisation address
    211 Mt Airy Rd, Basking Ridge, United States, 07920
    Public contact
    Medical Director, Daiichi Sankyo Inc., 1 9089927876, CTRinfo_us@daiichisankyo.com
    Scientific contact
    Medical Director, Daiichi Sankyo Inc., 1 9089927876, CTRinfo_us@daiichisankyo.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
    03 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study evaluates the efficacy, safety, and pharmacokinetics of Trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor 2 (HER2)-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC)
    Protection of trial subjects
    This study was conducted in compliance with the protocol, the ethical principles that have their origin in the Declaration of Helsinki, the International Council for Harmonisation (ICH) consolidated Guideline E6 for Good Clinical Practice (GCP) (CPMP/ICH/135/95), and applicable regulatory requirement(s), including the following: European Commission Directive (2001/20/EC Apr 2001) and/or European Commission Directive (2005/28/EC Apr 2005) and/or United States (US) Food and Drug Administration (FDA) GCP Regulations: Code of Federal Regulations Title 21, parts 11, 50, 54, 56 and 312 as appropriate and/or Japanese Ministry of Health, Labor and Welfare Ordinance No. 28 (27 March 1997) and/or The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics No. 1 (25 November 2014) and/or Other applicable local regulations
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Mar 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 4
    Country: Number of subjects enrolled
    Taiwan: 6
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    France: 8
    Country: Number of subjects enrolled
    Italy: 19
    Country: Number of subjects enrolled
    Japan: 43
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Worldwide total number of subjects
    122
    EEA total number of subjects
    43
    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)
    77
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 122 subjects who met all inclusion criteria and no exclusion criteria were randomized to T-DXd treatment in the United States, Asia-Pacific, and Europe.

    Pre-assignment
    Screening details
    		 Following adequate study explanation by the investigator or their designee, subjects voluntarily offered signed informed consent prior to participation in any study procedures.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 T-DXd 5.4 mg/kg Q3W
    Arm description
    		 Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab deruxtecan
    Investigational medicinal product code
    Other name
    Trastuzumab deruxtecan, T-DXd, DS-8201a
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous (IV) infusion administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

    Arm title
    		 T-DXd 6.4 mg/kg Q3W
    Arm description
    		 Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Trastuzumab deruxtecan
    Investigational medicinal product code
    Other name
    Trastuzumab deruxtecan, T-DXd, DS-8201a
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous (IV) infusion administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

    Number of subjects in period 1
    		T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Started
    83
    39
    Completed
    0
    0
    Not completed
    83
    39
         Adverse event, serious fatal
    2
    1
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    6
    4
         Progressive Disease
    64
    28
         other
    5
    1
         Clinical Progression
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 122
    Age Categorical
    Units: Subjects
    Age continuous
    99.99 denotes data is not available as it has been reported in the corresponding arm groups.
    Units: years
        arithmetic mean (standard deviation)
    		 99.99 ( 99.99 ) -
    Gender categorical
    Units: Subjects
        Male
    		 64 64
        Female
    		 58 58
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 50 50
        Black or African American
    		 0 0
        Asian
    		 66 66
        American Indian or Alaska Native
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Other
    		 6 6
    Subject analysis sets

    Subject analysis set title
    T-DXd 5.4 mg/kg Q3W
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

    Subject analysis set title
    T-DXd 6.4 mg/kg Q3W
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

    Subject analysis sets values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects
    82
    40
    Age Categorical
    Units: Subjects
    Age continuous
    99.99 denotes data is not available as it has been reported in the corresponding arm groups.
    Units: years
        arithmetic mean (standard deviation)
    58.5 ( 13.05 )
    61.1 ( 12.13 )
    Gender categorical
    Units: Subjects
        Male
    45
    19
        Female
    37
    21
    Race/Ethnicity, Customized
    Units: Subjects
        White
    35
    15
        Black or African American
    0
    0
        Asian
    42
    24
        American Indian or Alaska Native
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
        Other
    5
    1

    End points

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    End points reporting groups
    Reporting group title
    T-DXd 5.4 mg/kg Q3W
    Reporting group description
    		 Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

    Reporting group title
    T-DXd 6.4 mg/kg Q3W
    Reporting group description
    		 Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

    Subject analysis set title
    T-DXd 5.4 mg/kg Q3W
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

    Subject analysis set title
    T-DXd 6.4 mg/kg Q3W
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

    Primary: Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review Following IV Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2-overexpressing Metastatic Colorectal Cancer [1]
    End point description
    Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by blinded independent central review (BICR) based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions.
    End point type
    Primary
    End point timeframe
    6 months post-dose administration to data cut off, up to 20 months
    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: No statistical analyses for this end point.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40
    Units: percentage of participants
        number (confidence interval 95%)
    37.8 (27.3 to 49.2)
    27.5 (14.6 to 43.9)
    No statistical analyses for this end point

    Secondary: Duration of Response Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Duration of Response Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
    End point description
    DoR, defined as time from the initial response (CR or PR) by BICR and Investigator assessment until documented tumor progression or death from any cause. DoR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From the first documented evidence of a response (complete or partial) until disease progression or death, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40 [2]
    Units: months
    median (confidence interval 95%)
        BICR
    5.5 (4.2 to 8.1)
    5.5 (3.7 to 99999)
        Investigator
    5.6 (4.2 to 8.0)
    6.9 (4.9 to 9.9)
    Notes
    [2] - 99999 = Not estimable due to insufficient data.
    No statistical analyses for this end point

    Secondary: Confirmed Objective Response Rate by Investigator Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Confirmed Objective Response Rate by Investigator Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
    End point description
    Confirmed objective response rate (ORR), defined as the number (percentage) of participants with complete response (CR) or partial response (PR), were assessed by Investigator assessment based on RECIST version 1.1. CR was defined as the disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. ORR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From first dose administration to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40
    Units: percentage of participants
        number (confidence interval 95%)
    31.7 (21.9 to 42.9)
    30.0 (16.6 to 46.5)
    No statistical analyses for this end point

    Secondary: Disease Control Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Disease Control Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer
    End point description
    Disease Control Rate (DCR), defined as the proportion of subjects who achieved CR, PR, or SD for a minimum of 6 weeks during study treatment; DCR based on BICR and DCR based on Investigator assessments assessed according to RECIST version 1.1. DCR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From first dose administration to data cut off, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40
    Units: percentage of participants
    number (confidence interval 95%)
        BICR
    86.6 (77.3 to 93.1)
    85.0 (70.2 to 94.3)
        Investigator
    89.0 (80.2 to 94.9)
    85.0 (70.2 to 94.3)
    No statistical analyses for this end point

    Secondary: Progression Free Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Progression Free Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
    End point description
    Progression Free Survival (PFS) defined as the time from date of randomization/registration until first objective radiographic tumor progression or death from any cause, based on BICR and Investigator assessment according to RECIST version 1.1. PFS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From randomization to data cut off, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40
    Units: month
    median (confidence interval 95%)
        BICR
    5.8 (4.6 to 7.0)
    5.5 (4.2 to 7.0)
        Investigator
    5.8 (4.7 to 7.0)
    5.7 (4.2 to 8.3)
    No statistical analyses for this end point

    Secondary: Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Clinical Benefit Rate Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2) -Overexpressing Metastatic Colorectal Cancer
    End point description
    Clinical Benefit Rate (CBR), defined as proportion of subjects who achieved CR, PR, or SD for at least 6 months; CBR based on BICR and CBR based on Investigator assessments will both be determined based on RECIST version 1.1. CBR was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From first dose administration to data cut off, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40
    Units: percentage of participants
    number (confidence interval 95%)
        BICR
    42.5 (34.1 to 56.5)
    32.5 (18.6 to 49.1)
        Investigator
    51.2 (39.9 to 62.4)
    42.5 (27.0 to 59.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Percentage of Participants Reporting Treatment-emergent Adverse Events Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
    End point description
    A Treatment-emergent Adverse Events (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug or has worsened in severity or seriousness after initiating the study drug until 47 days after the last dose of the study drug. Serious AEs with an onset or worsening 48 days or more after the last dose of study drug, if considered related to study treatment. are also TEAEs. TEAEs were assessed in the Safety Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From first dose administration to data cut off, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    83
    39
    Units: percentage of participants
        number (not applicable)
    98.8
    100
    No statistical analyses for this end point

    Secondary: Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer

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    End point title
    		 Overall Survival Following Intravenous Administration of T-DXd in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Overexpressing Metastatic Colorectal Cancer
    End point description
    Overall Survival (OS) defined as the time from date of randomization/ registration until death from any cause, according to RECIST version 1.1. OS was assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From randomization to data cut off, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    40 [3]
    Units: months
        median (confidence interval 95%)
    13.4 (13.4 to 16.8)
    99999 (9.9 to 99999)
    Notes
    [3] - 99999 = Not estimable due to insufficient data.
    No statistical analyses for this end point

    Secondary: Serum Concentration of T-DXd

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    End point title
    		 Serum Concentration of T-DXd
    End point description
    Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI)
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    83 [4]
    39 [5]
    Units: ug/L
    geometric mean (geometric coefficient of variation)
        C1D1 - Before Infusion
    99999 ( 99999 )
    116000.00 ( 99999 )
        C1D1 - End of Infusion
    118452.77 ( 27.5 )
    134613.79 ( 18.1 )
        C1D1 - 5Hrs After Infusion
    123433.28 ( 23.0 )
    142399.71 ( 19.8 )
        C1D8 - 7 Days After Infusion
    22261.67 ( 38.9 )
    28142.80 ( 51.5 )
        C1D15 - 14 Days After Infusion
    8092.08 ( 61.7 )
    11396.97 ( 60.3 )
        C2D1 - Before Infusion
    2827.01 ( 118.8 )
    4420.63 ( 73.0 )
        C2D1 - End of Infusion
    109777.43 ( 67.2 )
    135637.46 ( 22.2 )
        C3D1 - Before Infusion
    4823.41 ( 83.6 )
    7543.17 ( 74.3 )
        C3D1 - End of Infusion
    122218.96 ( 25.8 )
    139264.52 ( 24.7 )
        C4D1 - Before Infusion
    5846.34 ( 89.5 )
    11013.81 ( 51.8 )
        C4D1 - End of Infusion
    124240.37 ( 23.4 )
    134129.68 ( 30.3 )
        C6D1 - Before Infusion
    7507.28 ( 74.5 )
    10793.89 ( 59.0 )
        C6D1 - End of Infusion
    117769.64 ( 25.3 )
    35753.88 ( 1079.6 )
    Notes
    [4] - 99999 = Not calculated due to concentrations below the lower limit of quantitation
    [5] - 99999 = Not calculated due to concentrations below the lower limit of quantitation
    No statistical analyses for this end point

    Secondary: Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody

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    End point title
    		 Serum Concentration of Total Anti-Human Epidermal Growth Factor Receptor 2 (HER2) Antibody
    End point description
    Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI)
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    83
    39
    Units: ug/L
    geometric mean (geometric coefficient of variation)
        C1D1 - Before Infusion
    5211.18 ( 388.5 )
    11934.79 ( 2058.9 )
        C1D1 - End of Infusion
    110871.93 ( 28.8 )
    121423.37 ( 20.3 )
        C1D1 - 5Hrs After Infusion
    107339.74 ( 23.4 )
    124274.05 ( 23.0 )
        C1D8 - 7 Days After Infusion
    27646.77 ( 40.3 )
    32741.77 ( 49.9 )
        C1D15 - 14 Days After Infusion
    10920.88 ( 71.7 )
    14293.10 ( 63.0 )
        C2D1 - Before Infusion
    3723.58 ( 123.1 )
    4841.90 ( 107.5 )
        C2D1 - End of Infusion
    106755.21 ( 66.0 )
    127427.43 ( 23.2 )
        C3D1 - Before Infusion
    6286.00 ( 93.2 )
    9100.39 ( 90.0 )
        C3D1 - End of Infusion
    114763.30 ( 22.8 )
    134111.33 ( 19.5 )
        C4D1 - Before Infusion
    7388.01 ( 101.8 )
    14007.95 ( 67.2 )
        C4D1 - End of Infusion
    113711.08 ( 21.5 )
    133956.61 ( 30.5 )
        C6D1 - Before Infusion
    9033.08 ( 94.9 )
    13535.33 ( 73.5 )
        C6D1 - End of Infusion
    104328.76 ( 35.4 )
    37091.52 ( 816.2 )
    No statistical analyses for this end point

    Secondary: Serum Concentration of Active Metabolite MAAA-1181a

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    End point title
    		 Serum Concentration of Active Metabolite MAAA-1181a
    End point description
    Descriptive statistics will be provided for serum concentration data of T-DXd, DXd, and total anti-HER2 antibody. Serum concentrations were assessed in the Pharmacokinetics Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    C1D1 (Before infusion (BI), end of infusion (EOI) and 5 hours after infusion), C1D8 (7 days after infusion), C1D15 (14 days after infusion), C2D1 (BI and EOI), C3D1 (BI and EOI), C4D1, (BI and EOI), C6D1 (BI and EOI)
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    83 [6]
    39 [7]
    Units: pg/mL
    geometric mean (geometric coefficient of variation)
        C1D1 - Before Infusion
    99999 ( 99999 )
    6250.00 ( 99999 )
        C1D1 - End of Infusion
    4101.40 ( 56.6 )
    4313.38 ( 45.3 )
        C1D1 - 5Hrs After Infusion
    12063.71 ( 52.8 )
    15773.44 ( 39.0 )
        C1D8 - 7 Days After Infusion
    1372.33 ( 75.8 )
    1761.02 ( 67.1 )
        C1D15 - 14 Days After Infusion
    475.30 ( 62.4 )
    602.43 ( 54.1 )
        C2D1 - Before Infusion
    209.06 ( 74.6 )
    291.07 ( 55.4 )
        C2D1 - End of Infusion
    1474.48 ( 71.2 )
    1649.91 ( 65.8 )
        C3D1 - Before Infusion
    279.56 ( 64.0 )
    427.33 ( 89.5 )
        C3D1 - End of Infusion
    1559.93 ( 52.6 )
    1647.92 ( 53.1 )
        C4D1 - Before Infusion
    284.38 ( 81.4 )
    494.17 ( 61.2 )
        C4D1 - End of Infusion
    1448.53 ( 48.5 )
    1404.67 ( 54.1 )
        C6D1 - Before Infusion
    332.07 ( 81.3 )
    578.72 ( 55.8 )
        C6D1 - End of Infusion
    1182.53 ( 36.8 )
    1512.25 ( 32.3 )
    Notes
    [6] - 99999 = Not calculated due to concentrations below the lower limit of quantitation
    [7] - 99999 = Not calculated due to concentrations below the lower limit of quantitation
    No statistical analyses for this end point

    Secondary: Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered T-DXd

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    End point title
    		 Percentage of Participants Positive for Treatment-emergent Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (NAb) in Participants Who Were Administered T-DXd
    End point description
    Immunogenicity will be assessed through characterization of incidence and titer of Anti-drug Antibodies (ADAs), the number and percentage of subjects positive for NAb of T-DXd by dose level will also be determined. ADAs and NAbs were assessed in the Immunogenicity Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Secondary
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    82
    39
    Units: percentage of participants
    number (not applicable)
        ADA
    1.3
    0
        NAb
    0
    0
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)

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    End point title
    		 Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30)
    End point description
    Exploratory outcome, results not included in this submission. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include 5 functional scales, 3 symptom scales, a global health status/QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items and no item occurs in more than 1 scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Patient questionnaires were assessed in the Full Analysis Set at data cut-off date of 01 Nov 2022.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months.
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: score
    Notes
    [8] - Exploratory outcome, results not included in this submission
    [9] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Other pre-specified: Patient-Reported Outcomes (PROs) in Patient's Global Impression of Treatment Tolerability (PGI-TT)

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    End point title
    		 Patient-Reported Outcomes (PROs) in Patient's Global Impression of Treatment Tolerability (PGI-TT)
    End point description
    Exploratory outcome, results not included in this submission. The PGI-TT item is included to assess how a patient perceives the overall tolerability of the study treatment over the past 7 days. This is a single-item questionnaire, and patients will rate the bother associated with any treatment-related symptoms using response options ranging from “Not at all” to “Very much”.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: score
    Notes
    [10] - Exploratory outcome, results not included in this submission
    [11] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Other pre-specified: Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIS)

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    End point title
    		 Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIS)
    End point description
    Exploratory outcome, results not included in this submission. The PGIS item is included to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. This is a single-item questionnaire, and patients will choose the response that best describes the severity of their overall cancer symptoms with options ranging from “No Symptoms” to “Very Severe”.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: score
    Notes
    [12] - Exploratory outcome, results not included in this submission
    [13] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Other pre-specified: Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIC)

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    End point title
    		 Patient-Reported Outcomes (PROs) in Patient Global Impression of Symptom Severity (PGIC)
    End point description
    Exploratory outcome, results not included in this submission. The PGIC item is included to assess how a patient perceives their overall change in health status since the start of study treatment. This is a single-item questionnaire, and patients will choose from response options ranging from “Much Better” to “Much Worse”.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: score
    Notes
    [14] - Exploratory outcome, results not included in this submission
    [15] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Other pre-specified: Inpatient Healthcare Resource Utilization

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    End point title
    		 Inpatient Healthcare Resource Utilization
    End point description
    Exploratory outcome, results not included in this submission. The impact of treatment and disease on healthcare resource use (including inpatient admissions, intensive care unit admissions, and length of stay in hospital) will be captured/collected in this study on an event-driven basis.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: score
    Notes
    [16] - Exploratory outcome, results not included in this submission
    [17] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Other pre-specified: Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Colorectal Cancer 29 (QLQ-CR29)

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    End point title
    		 Change From Baseline in Patient-Reported Outcomes (PROs) in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Colorectal Cancer 29 (QLQ-CR29)
    End point description
    Exploratory outcome, results not included in this submission. EORTC QLQ-CR29 is designed to be administered in addition to EORTC QLQ-C30. The EORTC QLQ-CR29 is a specific questionnaire for Colorectal Cancer. Scale from 0 to 100, A higher scale represents better function and a higher quality of life.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: score
    Notes
    [18] - Exploratory outcome, results not included in this submission
    [19] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Other pre-specified: Patient-Reported Outcomes (PROs) in the EuroQol Questionnaire (EQ) of 5 Dimensions (5D) on a Standardized 5- Level (5L) Descriptive Health Status Scale (EQ-5D-5L)

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    End point title
    		 Patient-Reported Outcomes (PROs) in the EuroQol Questionnaire (EQ) of 5 Dimensions (5D) on a Standardized 5- Level (5L) Descriptive Health Status Scale (EQ-5D-5L)
    End point description
    Exploratory outcome, results not included in this submission. The EQ-5D-5L is self-administered and consists of 2 parts, the EQ-5D-5L descriptive system and the EQ-visual analogue scale. On each dimension, a score of 1 indicates no patient problems in that dimension, 2 indicates slight problems in that dimension, 3 indicates moderate problems in that dimension, 4 indicates severe problems in that dimension and 5 indicates extreme problems in that dimension.
    End point type
    Other pre-specified
    End point timeframe
    From baseline to data cut off, up to approximately 19 months
    End point values
    		 T-DXd 5.4 mg/kg Q3W T-DXd 6.4 mg/kg Q3W
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: score
    Notes
    [20] - Exploratory outcome, results not included in this submission
    [21] - Exploratory outcome, results not included in this submission
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AE) were collected from the date of signing the informed consent form up to 47 days after last dose of the study drug, to the data cut off date of 20 Nov 2023, up to approximately 63 months.
    Adverse event reporting additional description
    A Treatment-emergent adverse event (TEAE) is defined as an AE that occurs, having been absent before the first dose of study drug, or has worsened in severity or seriousness after the initiating the study drug until 47 days after last dose of the study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25
    Reporting groups
    Reporting group title
    T-DXd 6.4 mg/kg Q3W
    Reporting group description
    		 Participants were randomized/registered to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).

    Reporting group title
    T-DXd 5.4 mg/kg Q3W
    Reporting group description
    		 Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).

    Serious adverse events
    		 T-DXd 6.4 mg/kg Q3W T-DXd 5.4 mg/kg Q3W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 39 (30.77%)
    21 / 83 (25.30%)
         number of deaths (all causes)
    13
    26
         number of deaths resulting from adverse events
    1
    2
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Inferior vena cava syndrome
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (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
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (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
    0 / 39 (0.00%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 39 (2.56%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 83 (3.61%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ileus paralytic
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 39 (2.56%)
    0 / 83 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 39 (2.56%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    Sacral pain
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         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
    0 / 39 (0.00%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 83 (2.41%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 83 (1.20%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 T-DXd 6.4 mg/kg Q3W T-DXd 5.4 mg/kg Q3W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 39 (97.44%)
    81 / 83 (97.59%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 39 (7.69%)
    1 / 83 (1.20%)
         occurrences all number
    3
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 39 (15.38%)
    17 / 83 (20.48%)
         occurrences all number
    20
    31
    Fatigue
         subjects affected / exposed
    6 / 39 (15.38%)
    16 / 83 (19.28%)
         occurrences all number
    9
    37
    Pyrexia
         subjects affected / exposed
    4 / 39 (10.26%)
    13 / 83 (15.66%)
         occurrences all number
    8
    19
    Malaise
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 83 (4.82%)
         occurrences all number
    5
    5
    Mucosal inflammation
         subjects affected / exposed
    2 / 39 (5.13%)
    4 / 83 (4.82%)
         occurrences all number
    2
    4
    Oedema peripheral
         subjects affected / exposed
    7 / 39 (17.95%)
    5 / 83 (6.02%)
         occurrences all number
    8
    5
    Dysgeusia
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 83 (1.20%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    5 / 39 (12.82%)
    5 / 83 (6.02%)
         occurrences all number
    6
    5
    Epistaxis
         subjects affected / exposed
    3 / 39 (7.69%)
    6 / 83 (7.23%)
         occurrences all number
    5
    10
    Dyspnoea
         subjects affected / exposed
    3 / 39 (7.69%)
    6 / 83 (7.23%)
         occurrences all number
    3
    7
    Interstitial lung disease
         subjects affected / exposed
    2 / 39 (5.13%)
    2 / 83 (2.41%)
         occurrences all number
    2
    2
    Cough
         subjects affected / exposed
    3 / 39 (7.69%)
    8 / 83 (9.64%)
         occurrences all number
    4
    10
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    16 / 39 (41.03%)
    18 / 83 (21.69%)
         occurrences all number
    47
    39
    Weight decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 83 (3.61%)
         occurrences all number
    2
    3
    Blood bilirubin increased
         subjects affected / exposed
    6 / 39 (15.38%)
    3 / 83 (3.61%)
         occurrences all number
    13
    5
    Blood alkaline phosphatase increased
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 83 (3.61%)
         occurrences all number
    4
    4
    Lymphocyte count decreased
         subjects affected / exposed
    2 / 39 (5.13%)
    4 / 83 (4.82%)
         occurrences all number
    2
    8
    Blood creatinine increased
         subjects affected / exposed
    2 / 39 (5.13%)
    4 / 83 (4.82%)
         occurrences all number
    3
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    7 / 39 (17.95%)
    10 / 83 (12.05%)
         occurrences all number
    13
    12
    White blood cell count decreased
         subjects affected / exposed
    7 / 39 (17.95%)
    11 / 83 (13.25%)
         occurrences all number
    22
    28
    Platelet count decreased
         subjects affected / exposed
    12 / 39 (30.77%)
    18 / 83 (21.69%)
         occurrences all number
    25
    41
    Alanine aminotransferase increased
         subjects affected / exposed
    6 / 39 (15.38%)
    8 / 83 (9.64%)
         occurrences all number
    12
    13
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 83 (3.61%)
         occurrences all number
    2
    3
    Headache
         subjects affected / exposed
    2 / 39 (5.13%)
    8 / 83 (9.64%)
         occurrences all number
    2
    10
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 39 (41.03%)
    22 / 83 (26.51%)
         occurrences all number
    43
    52
    Neutropenia
         subjects affected / exposed
    2 / 39 (5.13%)
    8 / 83 (9.64%)
         occurrences all number
    6
    22
    Thrombocytopenia
         subjects affected / exposed
    1 / 39 (2.56%)
    5 / 83 (6.02%)
         occurrences all number
    1
    6
    Eye disorders
    Retinal haemorrhage
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 83 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 39 (5.13%)
    7 / 83 (8.43%)
         occurrences all number
    4
    9
    Dyspepsia
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 83 (3.61%)
         occurrences all number
    2
    3
    Stomatitis
         subjects affected / exposed
    6 / 39 (15.38%)
    12 / 83 (14.46%)
         occurrences all number
    13
    17
    Vomiting
         subjects affected / exposed
    3 / 39 (7.69%)
    17 / 83 (20.48%)
         occurrences all number
    4
    29
    Diarrhoea
         subjects affected / exposed
    11 / 39 (28.21%)
    19 / 83 (22.89%)
         occurrences all number
    14
    38
    Constipation
         subjects affected / exposed
    6 / 39 (15.38%)
    20 / 83 (24.10%)
         occurrences all number
    8
    20
    Nausea
         subjects affected / exposed
    22 / 39 (56.41%)
    49 / 83 (59.04%)
         occurrences all number
    36
    102
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 83 (1.20%)
         occurrences all number
    4
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    11 / 39 (28.21%)
    19 / 83 (22.89%)
         occurrences all number
    12
    22
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 39 (5.13%)
    6 / 83 (7.23%)
         occurrences all number
    2
    6
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 39 (7.69%)
    2 / 83 (2.41%)
         occurrences all number
    4
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 39 (5.13%)
    4 / 83 (4.82%)
         occurrences all number
    2
    5
    Pneumonia
         subjects affected / exposed
    2 / 39 (5.13%)
    0 / 83 (0.00%)
         occurrences all number
    2
    0
    COVID-19
         subjects affected / exposed
    5 / 39 (12.82%)
    14 / 83 (16.87%)
         occurrences all number
    5
    16
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    4 / 39 (10.26%)
    6 / 83 (7.23%)
         occurrences all number
    5
    8
    Decreased appetite
         subjects affected / exposed
    6 / 39 (15.38%)
    25 / 83 (30.12%)
         occurrences all number
    9
    41

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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