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    Clinical Trial Results:
    An open-label, two-arm, randomized, single-stage phase II study of ATezolizumab in combination with dual HER2 blockade plus epirubicin as NEoadjuvant therapy for HER2-positive early breast cancer

    Summary
    EudraCT number
    		 2019-002364-27
    Trial protocol
    		 AT  
    Global end of trial date
    23 Nov 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Oct 2023
    First version publication date
    29 Sep 2023
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    update of contact

    Trial information

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    Trial identification
    Sponsor protocol code
    ABCSG_52
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Roche ID: ML40391
    Sponsors
    Sponsor organisation name
    ABCSG (Austrian Breast & Colorectal Cancer Study Group)
    Sponsor organisation address
    Nussdorfer Platz 8/12, Wien, Austria, 1190
    Public contact
    Trial Office, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.at
    Scientific contact
    Dr. Gabriel Rinnerthaler, ABCSG (Austrian Breast & Colorectal Cancer Study Group), +43 14089230, info@abcsg.at
    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
    30 May 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of a neoadjuvant immunochemotherapy regimen consisting of atezolizumab, trastuzumab, pertuzumab and epirubicin in regards to pathologic complete response (pCR = ypT0/is, ypN0) which is assessed in the overall study population at the time of surgery
    Protection of trial subjects
    The investigators ensured that patients were given comprehensive oral and written information about the nature, significance, and scope of the study prior to enrolment. The study specific patient information and informed consent form included language to encourage study participants to reach out to the Study Doctor / Study Team in case they had any questions, concerns or doubts. Section 16 specifically referenced a 24/7 contact person to reach out to, the ICF furthermore contained a reference to the local ombudsman / patient advocacy / data privacy officer and the trial sites had the opportunity to hand out Patient Cards to the recruited patients for use in case of emergency which includes the trial site’s contact details, information of the study drug(s) and the EudraCT-number. A dedicated DMC was established to ensure patient safety throughout the trial.
    Background therapy
    		 Background therapy of trastuzumab, pertuzumab and epirubicin only in treatment part 2 (in treatment arm A and arm B)
    Evidence for comparator
    		 No
    Actual start date of recruitment
    03 Jul 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
    Austria: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    46
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment phase for this study was 1.4 years. No follow up was done for this study.

    Pre-assignment
    Screening details
    		 A careful check of inclusion and exclusion criteria had to be performed by the Investigators / Site Teams and a centralized web based screeening and randomization system was subsequently used which assigned treatment arms electronically, i.e. randomized the participants into the previously described treatment arms.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Arm description
    		 For treatment part 1, arm A patients received 2 3-week cycles of pertuzumab (starting with 840 mg iv on cycle 1, followed by 420 mg iv for the subsequent cycle), 2 3-week cycles of trastuzumab (starting with 600 mg sc or 8 mg/kg iv on cycle 1, followed by 600 mg sc or 6 mg/kg iv for the subsequent cycle) and 2 3-week cycles of atezolizumab (1200 mg iv per cycle). For treatment part 2, arm A patients received 4 3-week cycles of atezolizumab (1200 mg iv per cycle), 4 3-week cycles pertuzumab (420 mg iv per cycle ), 4 3-week cycles trastuzumab (600 mg sc or 6 mg/kg iv per cycle) as well as 4 3-week cycles of epirubicin (90 mg/m² per cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atezolizumab
    Investigational medicinal product code
    RO5541267/F03
    Other name
    Tecentriq
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intraventricular use
    Dosage and administration details
    60 mg/ml

    Investigational medicinal product name
    Pertuzumab
    Investigational medicinal product code
    RO4368451
    Other name
    Perjeta
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/ml

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    180288-69-1
    Other name
    Herceptin
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg/ml

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    180288-69-1
    Other name
    Herceptin
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mg/ml

    Arm title
    		 Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Arm description
    		 For treatment part 1, arm B patients received 2 3-week cycles of pertuzumab (starting with 840 mg iv on cycle 1, followed by 420 mg iv for the subsequent cycle) and 2 3-week cycles of trastuzumab (starting with 600 mg sc or 8 mg/kg iv on cycle 1, followed by 600 mg sc or 6 mg/kg iv for the subsequent cycle). For treatment part 2, arm B patients received 4 3-week cycles of atezolizumab (1200 mg iv per cycle), 4 3-week cycles pertuzumab (420 mg iv per cycle ), 4 3-week cycles trastuzumab (600 mg sc or 6 mg/kg iv per cycle) as well as 4 3-week cycles of epirubicin (90 mg/m² per cycle).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pertuzumab
    Investigational medicinal product code
    RO4368451
    Other name
    Perjeta
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    30 mg/ml

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    180288-69-1
    Other name
    Herceptin
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    120 mg/ml

    Investigational medicinal product name
    Trastuzumab
    Investigational medicinal product code
    180288-69-1
    Other name
    Herceptin
    Pharmaceutical forms
    Powder for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 mg/ml

    Number of subjects in period 1
    		Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A) Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Started
    29
    29
    Completed
    28
    28
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Reporting group description
    		 For treatment part 1, arm A patients received 2 3-week cycles of pertuzumab (starting with 840 mg iv on cycle 1, followed by 420 mg iv for the subsequent cycle), 2 3-week cycles of trastuzumab (starting with 600 mg sc or 8 mg/kg iv on cycle 1, followed by 600 mg sc or 6 mg/kg iv for the subsequent cycle) and 2 3-week cycles of atezolizumab (1200 mg iv per cycle). For treatment part 2, arm A patients received 4 3-week cycles of atezolizumab (1200 mg iv per cycle), 4 3-week cycles pertuzumab (420 mg iv per cycle ), 4 3-week cycles trastuzumab (600 mg sc or 6 mg/kg iv per cycle) as well as 4 3-week cycles of epirubicin (90 mg/m² per cycle).

    Reporting group title
    Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Reporting group description
    		 For treatment part 1, arm B patients received 2 3-week cycles of pertuzumab (starting with 840 mg iv on cycle 1, followed by 420 mg iv for the subsequent cycle) and 2 3-week cycles of trastuzumab (starting with 600 mg sc or 8 mg/kg iv on cycle 1, followed by 600 mg sc or 6 mg/kg iv for the subsequent cycle). For treatment part 2, arm B patients received 4 3-week cycles of atezolizumab (1200 mg iv per cycle), 4 3-week cycles pertuzumab (420 mg iv per cycle ), 4 3-week cycles trastuzumab (600 mg sc or 6 mg/kg iv per cycle) as well as 4 3-week cycles of epirubicin (90 mg/m² per cycle).

    Reporting group values
    		 Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A) Pertuzumab+Trastuzumab+Epirubicin (Arm B) Total
    Number of subjects
    		 29 29 58
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 24 22 46
        From 65-84 years
    		 5 7 12
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (33 to 77) 58 (38 to 82) -
    Gender categorical
    Units: Subjects
        Female
    		 29 29 58
        Male
    		 0 0 0
    Menopausal status
    Menopausal status at randomization
    Units: Subjects
        Premenopausal (incl. perimenopausal)
    		 15 9 24
        Postmenopausal
    		 14 20 34
    TILs
    Amount of Tumor Infiltrating Lymphocytes (TILs)
    Units: Subjects
        <5%
    		 3 3 6
        >=5%
    		 26 26 52
    Hormone receptor status
    Hormone receptor status at randomization
    Units: Subjects
        Negative
    		 8 8 16
        Positive
    		 21 21 42
    Clinical prognostic stage
    Units: Subjects
        <=IIA
    		 23 22 45
        >=IIB
    		 6 7 13
    cT-stage
    Clinical tumor stage
    Units: Subjects
        T1c
    		 9 7 16
        T2
    		 16 19 35
        T3
    		 4 1 5
        T4b
    		 0 1 1
        T4c
    		 0 1 1
    cN-stage
    Clinical nodal status
    Units: Subjects
        N0
    		 17 18 35
        N1
    		 11 10 21
        N2
    		 0 1 1
        N2a
    		 1 0 1
    Tumor grade
    Units: Subjects
        G2
    		 12 16 28
        G3
    		 17 13 30
    Histological tumor type
    Units: Subjects
        Invasive carcinoma of no special type (NST)
    		 23 25 48
        Invasive lobular carcinoma
    		 2 0 2
        Mixed invasive NST and lobular carcinoma
    		 0 1 1
        Other
    		 4 3 7
    cM-stage
    Clinical metastasis status
    Units: Subjects
        M0
    		 29 29 58
    HER2 status
    Status of human epidermal growth factor receptor 2
    Units: Subjects
        Positive
    		 29 29 58
    BMI
    Body Mass Index
    Units: kg/m²
        median (full range (min-max))
    		 23.6 (19.5 to 37.8) 25.8 (19.1 to 39.4) -
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consists of all patients who were randomized. All cases with missing primary outcome of pathologic complete response (pCR yes/no) are considered as no pCR.

    Subject analysis sets values
    		 ITT
    Number of subjects
    58
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    46
        From 65-84 years
    12
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    57 (33 to 82)
    Gender categorical
    Units: Subjects
        Female
    58
        Male
    0
    Menopausal status
    Menopausal status at randomization
    Units: Subjects
        Premenopausal (incl. perimenopausal)
    24
        Postmenopausal
    34
    TILs
    Amount of Tumor Infiltrating Lymphocytes (TILs)
    Units: Subjects
        <5%
    6
        >=5%
    52
    Hormone receptor status
    Hormone receptor status at randomization
    Units: Subjects
        Negative
    16
        Positive
    42
    Clinical prognostic stage
    Units: Subjects
        <=IIA
    45
        >=IIB
    13
    cT-stage
    Clinical tumor stage
    Units: Subjects
        T1c
    16
        T2
    35
        T3
    5
        T4b
    1
        T4c
    1
    cN-stage
    Clinical nodal status
    Units: Subjects
        N0
    35
        N1
    21
        N2
    1
        N2a
    1
    Tumor grade
    Units: Subjects
        G2
    28
        G3
    30
    Histological tumor type
    Units: Subjects
        Invasive carcinoma of no special type (NST)
    48
        Invasive lobular carcinoma
    2
        Mixed invasive NST and lobular carcinoma
    1
        Other
    7
    cM-stage
    Clinical metastasis status
    Units: Subjects
        M0
    58
    HER2 status
    Status of human epidermal growth factor receptor 2
    Units: Subjects
        Positive
    58
    BMI
    Body Mass Index
    Units: kg/m²
        median (full range (min-max))
    24.5 (19.1 to 39.4)

    End points

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    End points reporting groups
    Reporting group title
    Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Reporting group description
    		 For treatment part 1, arm A patients received 2 3-week cycles of pertuzumab (starting with 840 mg iv on cycle 1, followed by 420 mg iv for the subsequent cycle), 2 3-week cycles of trastuzumab (starting with 600 mg sc or 8 mg/kg iv on cycle 1, followed by 600 mg sc or 6 mg/kg iv for the subsequent cycle) and 2 3-week cycles of atezolizumab (1200 mg iv per cycle). For treatment part 2, arm A patients received 4 3-week cycles of atezolizumab (1200 mg iv per cycle), 4 3-week cycles pertuzumab (420 mg iv per cycle ), 4 3-week cycles trastuzumab (600 mg sc or 6 mg/kg iv per cycle) as well as 4 3-week cycles of epirubicin (90 mg/m² per cycle).

    Reporting group title
    Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Reporting group description
    		 For treatment part 1, arm B patients received 2 3-week cycles of pertuzumab (starting with 840 mg iv on cycle 1, followed by 420 mg iv for the subsequent cycle) and 2 3-week cycles of trastuzumab (starting with 600 mg sc or 8 mg/kg iv on cycle 1, followed by 600 mg sc or 6 mg/kg iv for the subsequent cycle). For treatment part 2, arm B patients received 4 3-week cycles of atezolizumab (1200 mg iv per cycle), 4 3-week cycles pertuzumab (420 mg iv per cycle ), 4 3-week cycles trastuzumab (600 mg sc or 6 mg/kg iv per cycle) as well as 4 3-week cycles of epirubicin (90 mg/m² per cycle).

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population consists of all patients who were randomized. All cases with missing primary outcome of pathologic complete response (pCR yes/no) are considered as no pCR.

    Primary: Pathologic complete response (pCR)

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    End point title
    		 Pathologic complete response (pCR) [1]
    End point description
    Proportion (%) of patients with a pathologic complete response (pCR) together with its 95 %Wilson confidence interval in both arms combined and assessed in the ITT study population at the time of surgery is compared to a proportion of 40%
    End point type
    Primary
    End point timeframe
    At surgery
    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: The treatment arms were not compared against each other but the proportion (%) of patients with a pathologic complete response (pCR) in both arms combined was compared to a predefined proportion of 40%. It was not possible to document this single-arm comparison with a fixed value in the analysis part of the system. The estimated rate with the 95% confidence interval was therefore included in the description.
    End point values
    		 ITT
    Number of subjects analysed
    58 [2]
    Units: Subjects
        pCR
    35
        No PCR
    23
    Notes
    [2] - The estimated pCR rate is 60.3% with a two-sided 95% confidence interval (CI) of [47.5, 71.9].
    No statistical analyses for this end point

    Secondary: Residual Cancer Burden (RCB)

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    End point title
    		 Residual Cancer Burden (RCB)
    End point description
    Proportion of patients with Residual Cancer Burden RCB 0/I (RCB index ≤1.36) together with its 95 %Wilson confidence interval in both arms combined and assessed in the ITT study population at the time of surgery
    End point type
    Secondary
    End point timeframe
    At surgery
    End point values
    		 ITT
    Number of subjects analysed
    58
    Units: Subjects
        RCB 0/I
    44
        RCB II/III
    11
        Not evaluated
    3
    No statistical analyses for this end point

    Secondary: Overall Response Rate (ORR)

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    End point title
    		 Overall Response Rate (ORR)
    End point description
    Proportion of patients with overall response defined as radiographic complete or radiographic partial response (rCR or rPR) according to modified Response Evaluation Criteria in Solid Tumors (RECIST) together with its 95 %Wilson confidence interval in both arms combined and assessed in the ITT study population at the time of surgery
    End point type
    Secondary
    End point timeframe
    At surgery
    End point values
    		 ITT
    Number of subjects analysed
    58
    Units: Subjects
        rCR+rPR (complete or partial response)
    50
        rSD (stable disease)
    6
        Not evaluated
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    (S)AE reporting was mandatory from the date of informed consent form signature (i.e., screening phase) until 42 days after the last dose of neoadjuvant study treatment.
    Adverse event reporting additional description
    Screening Phase: only AEs deemed to be serious (SAEs) and related to protocol mandated and not routinely performed procedures have to be reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A)
    Reporting group description
    		 -

    Reporting group title
    Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Reporting group description
    		 -

    Serious adverse events
    		 Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A) Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 29 (17.24%)
    6 / 29 (20.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
    Additional description: Infusion related reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiomyopathy
    Additional description: Cardiomyopathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
    Additional description: General physical health deterioration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (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
    Additional description: Febrile neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Alveolar osteitis
    Additional description: Alveolar osteitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
    Additional description: Febrile infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 29 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
    Additional description: COVID-19
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    1 / 29 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Atezolizumab+Pertuzumab+Trastuzumab+Epirubicin (Arm A) Pertuzumab+Trastuzumab+Epirubicin (Arm B)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 29 (100.00%)
    29 / 29 (100.00%)
    Vascular disorders
    Hot flush
    Additional description: Hot flush
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    3
    2
    Hypertension
    Additional description: Hypertension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Hypotension
    Additional description: Hypotension
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Thrombophlebitis
    Additional description: Thrombophlebitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Influenza like illness
    Additional description: Influenza like illness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Fatigue
    Additional description: Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    14 / 29 (48.28%)
    17 / 29 (58.62%)
         occurrences all number
    29
    35
    Chills
    Additional description: Chills
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 29 (24.14%)
    7 / 29 (24.14%)
         occurrences all number
    8
    7
    Pyrexia
    Additional description: Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    7 / 29 (24.14%)
         occurrences all number
    8
    8
    Pain
    Additional description: Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Mucosal inflammation
    Additional description: Mucosal inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    5 / 29 (17.24%)
         occurrences all number
    8
    6
    Reproductive system and breast disorders
    Breast pain
    Additional description: Breast pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Vulvovaginal dryness
    Additional description: Vulvovaginal dryness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Epistaxis
    Additional description: Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Rhinorrhoea
    Additional description: Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    2
    1
    Nasal dryness
    Additional description: Nasal dryness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 29 (13.79%)
         occurrences all number
    1
    4
    Cough
    Additional description: Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    Psychiatric disorders
    Sleep disorder
    Additional description: Sleep disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    Infusion related reaction
    Additional description: Infusion related reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Nervous system disorders
    Polyneuropathy
    Additional description: Polyneuropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    5
    2
    Paraesthesia
    Additional description: Paraesthesia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    4
    2
    Headache
    Additional description: Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 29 (24.14%)
    8 / 29 (27.59%)
         occurrences all number
    7
    16
    Ageusia
    Additional description: Ageusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Dysgeusia
    Additional description: Dysgeusia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    4
    1
    Taste disorder
    Additional description: Taste disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    3
    5
    Blood and lymphatic system disorders
    Neutropenia
    Additional description: Neutropenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 29 (20.69%)
    4 / 29 (13.79%)
         occurrences all number
    9
    7
    Leukopenia
    Additional description: Leukopenia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    3
    1
    Anaemia
    Additional description: Anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    3 / 29 (10.34%)
         occurrences all number
    6
    4
    Ear and labyrinth disorders
    Vertigo
    Additional description: Vertigo
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    10
    4
    Eye disorders
    Dry eye
    Additional description: Dry eye
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    1
    4
    Visual impairment
    Additional description: Visual impairment
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Gastrointestinal disorders
    Vomiting
    Additional description: Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    4
    6
    Diarrhoea
    Additional description: Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 29 (58.62%)
    18 / 29 (62.07%)
         occurrences all number
    42
    43
    Nausea
    Additional description: Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    20 / 29 (68.97%)
    20 / 29 (68.97%)
         occurrences all number
    38
    45
    Dyspepsia
    Additional description: Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    5 / 29 (17.24%)
         occurrences all number
    2
    8
    Abdominal pain upper
    Additional description: Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Abnormal faeces
    Additional description: Abnormal faeces
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Constipation
    Additional description: Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    8 / 29 (27.59%)
         occurrences all number
    9
    15
    Stomatitis
    Additional description: Stomatitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    3 / 29 (10.34%)
         occurrences all number
    2
    4
    Hepatobiliary disorders
    Hypertransaminasaemia
    Additional description: Hypertransaminasaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    2
    3
    Skin and subcutaneous tissue disorders
    Alopecia
    Additional description: Alopecia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 29 (41.38%)
    8 / 29 (27.59%)
         occurrences all number
    14
    10
    Dry skin
    Additional description: Dry skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    5 / 29 (17.24%)
         occurrences all number
    4
    5
    Eczema
    Additional description: Eczema
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 29 (10.34%)
         occurrences all number
    0
    5
    Rash
    Additional description: Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    4 / 29 (13.79%)
         occurrences all number
    3
    5
    Pruritus
    Additional description: Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    1 / 29 (3.45%)
         occurrences all number
    3
    2
    Nail disorder
    Additional description: Nail disorder
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Intertrigo
    Additional description: Intertrigo
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Renal and urinary disorders
    Dysuria
    Additional description: Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Endocrine disorders
    Immune-mediated hyperthyroidism
    Additional description: Immune-mediated hyperthyroidism
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Musculoskeletal and connective tissue disorders
    Pain in extremity
    Additional description: Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    3
    Myalgia
    Additional description: Myalgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 29 (10.34%)
    2 / 29 (6.90%)
         occurrences all number
    3
    3
    Muscle spasms
    Additional description: Muscle spasms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Back pain
    Additional description: Back pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    3 / 29 (10.34%)
         occurrences all number
    3
    3
    Arthralgia
    Additional description: Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 29 (17.24%)
    2 / 29 (6.90%)
         occurrences all number
    5
    3
    Infections and infestations
    Urinary tract infection
    Additional description: Urinary tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 29 (13.79%)
    1 / 29 (3.45%)
         occurrences all number
    7
    2
    Rhinitis
    Additional description: Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    2 / 29 (6.90%)
         occurrences all number
    2
    2
    Respiratory tract infection
    Additional description: Respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 29 (6.90%)
         occurrences all number
    1
    2
    Oral herpes
    Additional description: Oral herpes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
    Additional description: Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 29 (3.45%)
    5 / 29 (17.24%)
         occurrences all number
    1
    5
    Candida infection
    Additional description: Candida infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 29 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Decreased appetite
    Additional description: Decreased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 29 (20.69%)
    4 / 29 (13.79%)
         occurrences all number
    7
    6

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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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    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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