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    Clinical Trial Results:
    Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

    Summary
    EudraCT number
    		 2020-004643-80
    Trial protocol
    		 FR   HU   DE   BE   NL   CZ   IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Aug 2025
    First version publication date
    09 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DS1062-A-U301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04656652
    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
    Global Clinical Director, Daiichi Sankyo Inc., 07920 9089926400, CTRinfo_us@daiichisankyo.com
    Scientific contact
    Global Clinical Director, Daiichi Sankyo Inc, 07920 9089926400, 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
    Interim
    Date of interim/final analysis
    10 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 May 2024
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of DS-1062a with that of docetaxel, as measured by PFS and OS, for subjects with NSCLC without actionable genomic alterations previously treated with platinum-based chemotherapy and an α-PD- 1/α-PD-L1 monoclonal antibody
    Protection of trial subjects
    The study protocol, amendments, the informed consent form(s) (ICF[s]), and information sheets were approved by the appropriate and applicable Independent Ethics Committees (IECs) or Institutional Review Boards (IRBs). The 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).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 2020
    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
    Canada: 10
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    United States: 50
    Country: Number of subjects enrolled
    Argentina: 4
    Country: Number of subjects enrolled
    China: 13
    Country: Number of subjects enrolled
    Japan: 107
    Country: Number of subjects enrolled
    Korea, Republic of: 92
    Country: Number of subjects enrolled
    Singapore: 4
    Country: Number of subjects enrolled
    Taiwan: 15
    Country: Number of subjects enrolled
    Belgium: 12
    Country: Number of subjects enrolled
    Czechia: 4
    Country: Number of subjects enrolled
    France: 96
    Country: Number of subjects enrolled
    Germany: 8
    Country: Number of subjects enrolled
    Hungary: 1
    Country: Number of subjects enrolled
    Italy: 21
    Country: Number of subjects enrolled
    Netherlands: 19
    Country: Number of subjects enrolled
    Poland: 16
    Country: Number of subjects enrolled
    Russian Federation: 16
    Country: Number of subjects enrolled
    Spain: 88
    Country: Number of subjects enrolled
    Switzerland: 5
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Australia: 15
    Worldwide total number of subjects
    604
    EEA total number of subjects
    265
    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)
    317
    From 65 to 84 years
    285
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 605 participants , including 1 participant who was randomized twice, were randomized to the study in Europe, Asia, North America, South America, and Australia.

    Pre-assignment
    Screening details
    		 811 participants were screened for the study, in which 604 participants were randomized and included in the Full Analysis Set.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DS-1062a 6.0 mg/kg
    Arm description
    		 Participants were randomized to receive 6.0 mg/kg of DS-1062a.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Datopotamab deruxtecan
    Investigational medicinal product code
    Other name
    Datopotamab deruxtecan, Dato-DXd, DS1062a
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants were randomized to receive 6.0 mg/kg of DS-1062a.

    Arm title
    		 Docetaxel 75 mg/m^2
    Arm description
    		 Participants were randomized to receive 75 mg/m^2 docetaxel.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion in pre-filled syringe
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants were randomized to receive 75 mg/m^2 docetaxel.

    Number of subjects in period 1
    		DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2
    Started
    299
    305
    Completed
    68
    62
    Not completed
    231
    243
         Adverse event, serious fatal
    213
    212
         Consent withdrawn by subject
    15
    29
         Other
    1
    -
         Lost to follow-up
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DS-1062a 6.0 mg/kg
    Reporting group description
    		 Participants were randomized to receive 6.0 mg/kg of DS-1062a.

    Reporting group title
    Docetaxel 75 mg/m^2
    Reporting group description
    		 Participants were randomized to receive 75 mg/m^2 docetaxel.

    Reporting group values
    		 DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2 Total
    Number of subjects
    		 299 305
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ( 9.09 ) 62.6 ( 10.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 116 95 211
        Male
    		 183 210 393
    Age categorical
    Units: Subjects
        <= 18 years
    		 0 0 0
        Between 18 and 65
    		 162 155 317
        >= 65 years
    		 137 150 287
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 1
        Asian
    		 121 120 241
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 6 4 10
        White
    		 123 126 249
        Other
    		 42 47 89
        Unknown or Not Reported
    		 6 8 14

    End points

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    End points reporting groups
    Reporting group title
    DS-1062a 6.0 mg/kg
    Reporting group description
    		 Participants were randomized to receive 6.0 mg/kg of DS-1062a.

    Reporting group title
    Docetaxel 75 mg/m^2
    Reporting group description
    		 Participants were randomized to receive 75 mg/m^2 docetaxel.

    Primary: Overall Survival (OS) Following DS-1062a Versus Docetaxel

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    End point title
    		 Overall Survival (OS) Following DS-1062a Versus Docetaxel [1]
    End point description
    OS is defined as the time from randomization to the date of death due to any cause.
    End point type
    Primary
    End point timeframe
    From randomization until date of death due to any cause, up to to approximately 38 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 have been specified for this primary endpoint.
    End point values
    		 DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2
    Number of subjects analysed
    299
    305
    Units: months
        median (standard deviation)
    12.9 ( 11.0 )
    11.8 ( 10.1 )
    No statistical analyses for this end point

    Primary: Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel

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    End point title
    		 Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel [2]
    End point description
    PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
    End point type
    Primary
    End point timeframe
    From randomization until disease progression or death (whichever occurs first), up to approximately 27 months
    Notes
    [2] - 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 have been specified for this primary endpoint.
    End point values
    		 DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2
    Number of subjects analysed
    299
    305
    Units: months
        median (confidence interval 95%)
    4.4 (4.2 to 5.6)
    3.7 (2.9 to 4.2)
    No statistical analyses for this end point

    Secondary: Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel

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    End point title
    		 Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    End point description
    ORR is defined as the proportion of subjects who achieved a best overall response (BOR) of complete response (CR) or partial response (PR), as assessed by BICR and investigator per RECIST v1.1.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
    End point values
    		 DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2
    Number of subjects analysed
    299
    305
    Units: participants
        Assessed by Blinded Independent Central Review
    79
    39
        Assessed by Investigator
    74
    44
    No statistical analyses for this end point

    Secondary: Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel

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    End point title
    		 Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    End point description
    DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic Progressive Disease or death due to any cause, whichever occurs first.
    End point type
    Secondary
    End point timeframe
    From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months
    End point values
    		 DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2
    Number of subjects analysed
    299
    305
    Units: months
    median (confidence interval 95%)
        Assessed by Blinded Independent Central Review
    7.1 (5.6 to 10.9)
    5.6 (5.4 to 8.1)
        Assessed by Investigator
    9.6 (6.7 to 11.1)
    6.4 (5.1 to 8.3)
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel

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    End point title
    		 Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
    End point description
    PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
    End point type
    Secondary
    End point timeframe
    From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
    End point values
    		 DS-1062a 6.0 mg/kg Docetaxel 75 mg/m^2
    Number of subjects analysed
    299
    305
    Units: months
        median (confidence interval 95%)
    4.4 (4.2 to 5.5)
    3.0 (2.8 to 4.0)
    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 28 days after last dose of the study drug, up 43 months.
    Adverse event reporting additional description
    A Treatment-emergent adverse event (TEAE) is defined as an AE with a start or worsening date on or after the start date of study treatment until 35 days since date of last dose of study treatment. Adverse Events used Safety Analysis Set, while Mortality used Full Analysis Set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Docetaxel 75 mg/m^2
    Reporting group description
    		 Participants were randomized to receive 75 mg/m^2 docetaxel.

    Reporting group title
    DS-1062a 6.0 mg/kg
    Reporting group description
    		 Participants were randomized to receive 6.0 mg/kg of DS-1062a.

    Serious adverse events
    		 Docetaxel 75 mg/m^2 DS-1062a 6.0 mg/kg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    111 / 290 (38.28%)
    92 / 297 (30.98%)
         number of deaths (all causes)
    218
    215
         number of deaths resulting from adverse events
    9
    15
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    4 / 290 (1.38%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 290 (0.34%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         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 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sudden death
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 290 (1.03%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    2 / 290 (0.69%)
    4 / 297 (1.35%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cough
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchial obstruction
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    4 / 290 (1.38%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    2 / 290 (0.69%)
    4 / 297 (1.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    5 / 290 (1.72%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    6 / 7
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumonitis
         subjects affected / exposed
    6 / 290 (2.07%)
    13 / 297 (4.38%)
         occurrences causally related to treatment / all
    6 / 7
    14 / 16
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Respiratory failure
         subjects affected / exposed
    2 / 290 (0.69%)
    3 / 297 (1.01%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical condition abnormal
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neutrophil count decreased
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Hypotonia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intrac
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (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
    11 / 290 (3.79%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    11 / 11
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelosuppression
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    0 / 290 (0.00%)
    3 / 297 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Keratitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative keratitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 290 (0.00%)
    5 / 297 (1.68%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 290 (0.00%)
    3 / 297 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypercalcaemia of malignancy
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pathological fracture
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (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
    2 / 290 (0.69%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    2 / 290 (0.69%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 290 (2.76%)
    5 / 297 (1.68%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bronchitis
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    3 / 290 (1.03%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    0 / 290 (0.00%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastroenteritis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 290 (0.69%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis infective
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 290 (0.34%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    23 / 290 (7.93%)
    15 / 297 (5.05%)
         occurrences causally related to treatment / all
    3 / 26
    6 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Enterocolitis infectious
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 290 (0.69%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia serratia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 290 (0.69%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 290 (1.03%)
    2 / 297 (0.67%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Septic shock
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (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
    Hyperglycaemia
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 290 (0.00%)
    1 / 297 (0.34%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 290 (0.34%)
    0 / 297 (0.00%)
         occurrences causally related to treatment / all
    1 / 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
    		 Docetaxel 75 mg/m^2 DS-1062a 6.0 mg/kg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    262 / 290 (90.34%)
    273 / 297 (91.92%)
    Investigations
    Aspartate aminotransferase increased
         subjects affected / exposed
    8 / 290 (2.76%)
    15 / 297 (5.05%)
         occurrences all number
    14
    27
    Alanine aminotransferase increased
         subjects affected / exposed
    9 / 290 (3.10%)
    16 / 297 (5.39%)
         occurrences all number
    12
    30
    Blood creatinine increased
         subjects affected / exposed
    4 / 290 (1.38%)
    16 / 297 (5.39%)
         occurrences all number
    5
    21
    Neutrophil count decreased
         subjects affected / exposed
    41 / 290 (14.14%)
    9 / 297 (3.03%)
         occurrences all number
    99
    27
    Weight decreased
         subjects affected / exposed
    13 / 290 (4.48%)
    28 / 297 (9.43%)
         occurrences all number
    16
    37
    White blood cell count decreased
         subjects affected / exposed
    27 / 290 (9.31%)
    6 / 297 (2.02%)
         occurrences all number
    60
    15
    Nervous system disorders
    Peripheral sensory neuropathy
         subjects affected / exposed
    15 / 290 (5.17%)
    4 / 297 (1.35%)
         occurrences all number
    19
    4
    Paraesthesia
         subjects affected / exposed
    18 / 290 (6.21%)
    4 / 297 (1.35%)
         occurrences all number
    20
    4
    Neuropathy peripheral
         subjects affected / exposed
    28 / 290 (9.66%)
    4 / 297 (1.35%)
         occurrences all number
    45
    4
    Headache
         subjects affected / exposed
    14 / 290 (4.83%)
    28 / 297 (9.43%)
         occurrences all number
    15
    35
    Dysgeusia
         subjects affected / exposed
    14 / 290 (4.83%)
    17 / 297 (5.72%)
         occurrences all number
    17
    18
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    72 / 290 (24.83%)
    50 / 297 (16.84%)
         occurrences all number
    140
    90
    Leukopenia
         subjects affected / exposed
    20 / 290 (6.90%)
    6 / 297 (2.02%)
         occurrences all number
    32
    7
    Neutropenia
         subjects affected / exposed
    40 / 290 (13.79%)
    6 / 297 (2.02%)
         occurrences all number
    66
    7
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    69 / 290 (23.79%)
    70 / 297 (23.57%)
         occurrences all number
    107
    139
    Chest pain
         subjects affected / exposed
    12 / 290 (4.14%)
    17 / 297 (5.72%)
         occurrences all number
    12
    19
    Fatigue
         subjects affected / exposed
    48 / 290 (16.55%)
    48 / 297 (16.16%)
         occurrences all number
    70
    59
    Malaise
         subjects affected / exposed
    30 / 290 (10.34%)
    21 / 297 (7.07%)
         occurrences all number
    45
    34
    Oedema peripheral
         subjects affected / exposed
    40 / 290 (13.79%)
    13 / 297 (4.38%)
         occurrences all number
    56
    15
    Pyrexia
         subjects affected / exposed
    35 / 290 (12.07%)
    22 / 297 (7.41%)
         occurrences all number
    49
    25
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    17 / 290 (5.86%)
    23 / 297 (7.74%)
         occurrences all number
    17
    23
    Dry eye
         subjects affected / exposed
    3 / 290 (1.03%)
    21 / 297 (7.07%)
         occurrences all number
    3
    23
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    65 / 290 (22.41%)
    38 / 297 (12.79%)
         occurrences all number
    90
    54
    Dry mouth
         subjects affected / exposed
    9 / 290 (3.10%)
    16 / 297 (5.39%)
         occurrences all number
    9
    20
    Nausea
         subjects affected / exposed
    54 / 290 (18.62%)
    112 / 297 (37.71%)
         occurrences all number
    74
    166
    Vomiting
         subjects affected / exposed
    26 / 290 (8.97%)
    47 / 297 (15.82%)
         occurrences all number
    37
    65
    Constipation
         subjects affected / exposed
    42 / 290 (14.48%)
    58 / 297 (19.53%)
         occurrences all number
    47
    70
    Stomatitis
         subjects affected / exposed
    47 / 290 (16.21%)
    148 / 297 (49.83%)
         occurrences all number
    65
    279
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    46 / 290 (15.86%)
    51 / 297 (17.17%)
         occurrences all number
    55
    65
    Cough
         subjects affected / exposed
    37 / 290 (12.76%)
    45 / 297 (15.15%)
         occurrences all number
    46
    56
    Oropharyngeal pain
         subjects affected / exposed
    4 / 290 (1.38%)
    16 / 297 (5.39%)
         occurrences all number
    4
    18
    Haemoptysis
         subjects affected / exposed
    15 / 290 (5.17%)
    10 / 297 (3.37%)
         occurrences all number
    16
    15
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    14 / 290 (4.83%)
    34 / 297 (11.45%)
         occurrences all number
    14
    40
    Rash
         subjects affected / exposed
    21 / 290 (7.24%)
    40 / 297 (13.47%)
         occurrences all number
    26
    45
    Alopecia
         subjects affected / exposed
    101 / 290 (34.83%)
    95 / 297 (31.99%)
         occurrences all number
    115
    115
    Dry skin
         subjects affected / exposed
    9 / 290 (3.10%)
    21 / 297 (7.07%)
         occurrences all number
    10
    21
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    10 / 290 (3.45%)
    15 / 297 (5.05%)
         occurrences all number
    11
    16
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    25 / 290 (8.62%)
    6 / 297 (2.02%)
         occurrences all number
    33
    7
    Back pain
         subjects affected / exposed
    17 / 290 (5.86%)
    19 / 297 (6.40%)
         occurrences all number
    21
    23
    Arthralgia
         subjects affected / exposed
    33 / 290 (11.38%)
    27 / 297 (9.09%)
         occurrences all number
    46
    36
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    3 / 290 (1.03%)
    15 / 297 (5.05%)
         occurrences all number
    3
    19
    COVID-19
         subjects affected / exposed
    23 / 290 (7.93%)
    34 / 297 (11.45%)
         occurrences all number
    23
    38
    Pneumonia
         subjects affected / exposed
    12 / 290 (4.14%)
    20 / 297 (6.73%)
         occurrences all number
    13
    25
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    63 / 290 (21.72%)
    86 / 297 (28.96%)
         occurrences all number
    70
    119
    Hypoalbuminaemia
         subjects affected / exposed
    12 / 290 (4.14%)
    17 / 297 (5.72%)
         occurrences all number
    13
    25

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2023
    The main purpose of this amendment is to update the safety information for the DS-1062a investigational product.

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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