Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Phase-IIb-Study to Evaluate the Effect of a Neoadjuvant Chemotherapy with Docetaxel, Epirubicine and Cyclphosphamide (TEC) in Patients with primary HER-2 neu Negative Mammacarcinoma

    Summary
    EudraCT number
    		 2008-003064-19
    Trial protocol
    		 DE  
    Global end of trial date
    07 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Aug 2020
    First version publication date
    02 Aug 2020
    Other versions
    Summary report(s)
    		 Study report

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    NeoTEC
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 DRKS: DRKS00000162
    Sponsors
    Sponsor organisation name
    University of Leipzig
    Sponsor organisation address
    Ritterstr. 26, Leipzig, Germany, 04109
    Public contact
    Coordinating Investigator, Coordinating Investigator, St. Elisabeth-Krankenhaus Leipzig, Brustzentrum, Leipzig, 0049 341 39 59 493, Dagmar.Langanke@ek-leipzig.de
    Scientific contact
    Coordinating Investigator, St. Elisabeth-Krankenhaus Leipzig, Brustzentrum, Leipzig, 0049 341 39 59 493, Dagmar.Langanke@ek-leipzig.de
    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 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Estimation of the complete remission rate of invasive tumor cells in the breast confirmed by histological examinations, at surgery. The treatment of the mammacarcinoma consists in this study normally on 6 chemotherapy cycles of the combination Docetaxel, Epirubicine and Cyclophosphamide (TEC-therapy). Followed by the surgery of the carcinoma, which takes place on day 28 after the last chemotherapy application, at the latest. An evaluation of the response of the treatment is performed after 2 and 4 cycles by use of palpation and mamma sonography. In case of complete remission, partial remission and no change the patient receives further two TEC cycles. In case of progress under therapy the surgery is immediately performed.
    Protection of trial subjects
    During the course of the trial, every patient was monitored closely concerning the described safety parameters. Besides the documentation of adverse events , this encompasses the following parmeters: - physical examinations - Performancestatus (ECOG, Karnofsky Index) - Labory parameters
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Mar 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 152
    Worldwide total number of subjects
    152
    EEA total number of subjects
    152
    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)
    124
    From 65 to 84 years
    28
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Between March 2009 and February 2011, 152 patients were recruited to the NeoTEC study in 15 Trial sites in Germany. The trial containted one arm only.

    Pre-assignment
    Screening details
    		 Eligibility for the study if: - Women with histologically verified mamma carcinoma (assessment of estrogen and progesterone receptors, grading, negative HER-2/neu status) - All receptor-negative mamma carcinoma starting from cT1c, all receptor-positive mamma carcinoma starting from cT3, cT4 includes inflammatory mamma carcinoma

    Period 1
    Period 1 title
    treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Study arm
    Arm description
    		 Chemotherapy combination of Docetaxel, Epirubicine and Cyclophosphamide with breast preserving surgery
    Arm type
    		 Experimental

    Investigational medicinal product name
    Docetaxel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Docetaxel 75 mg/m2 every 3 weeks for 6 cycles

    Investigational medicinal product name
    Epirubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Epirubicin 75 mg/m2 every 3 weeks for 6 cycles

    Investigational medicinal product name
    Cyclophosphamid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m2 every 3 weeks for 6 cycles

    Number of subjects in period 1
    		Study arm
    Started
    152
    Completed
    148
    Not completed
    4
         Adverse event, serious fatal
    2
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    1
    Period 2
    Period 2 title
    Follow-up
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow-up
    Arm description
    		 5 years Follow-up after study treatment
    Arm type
    		 Follow-up

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Follow-up
    Started
    148
    Completed
    126
    Not completed
    22
         change to another treating institution
    4
         removal to another city/contry
    2
         Lost to follow-up
    15
         termination due to psychosocial problems
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    treatment period
    Reporting group description
    		 -

    Reporting group values
    		 treatment period Total
    Number of subjects
    		 152 152
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 52.7 ± 11.2 -
    Gender categorical
    Units: Subjects
        Female
    		 152 152
        Male
    		 0 0
    ECOG
    Units: Subjects
        full activity
    		 125 125
        restricted activity
    		 23 23
        self-supply possible
    		 3 3
        no data
    		 1 1
    concomitant disease/s
    Units: Subjects
        yes
    		 79 79
        no
    		 73 73
    type of tumor
    Units: Subjects
        invasive-ductal
    		 134 134
        invasice-lobular
    		 12 12
        other
    		 5 5
        no data
    		 1 1
    receptor status
    Units: Subjects
        ER and PR-positive
    		 55 55
        one of both positive
    		 96 96
        no data
    		 1 1
    TNM stage (sono)
    Units: Subjects
        T1N0M0
    		 4 4
        T1N1M0
    		 9 9
        T2N0M0
    		 28 28
        T2N1M0
    		 68 68
        T2N2M0
    		 2 2
        T2N3M0
    		 2 2
        T3N0M0
    		 5 5
        T3N1M0
    		 9 9
        T4N0M0
    		 11 11
        T4N1M0
    		 12 12
        T4N2M0
    		 1 1
        no data
    		 1 1
    menopause
    Units: Subjects
        yes
    		 85 85
        no
    		 66 66
        not available
    		 1 1
    Body Surface Area
    Units: m²
        arithmetic mean (standard deviation)
    		 1.81 ± 0.19 -
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    		 28.3 ± 6.0 -
    tumor size (sono)
    Units: mm²
        arithmetic mean (standard deviation)
    		 1459 ± 6837 -
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Since this study was one-armed, the overall description of all patients is the only useful information

    Subject analysis sets values
    		 FAS
    Number of subjects
    152
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    52.7 ± 11.2
    Gender categorical
    Units: Subjects
        Female
    152
        Male
    0
    ECOG
    Units: Subjects
        full activity
    125
        restricted activity
    23
        self-supply possible
    3
        no data
    1
    concomitant disease/s
    Units: Subjects
        yes
    79
        no
    73
    type of tumor
    Units: Subjects
        invasive-ductal
    134
        invasice-lobular
    12
        other
    5
        no data
    1
    receptor status
    Units: Subjects
        ER and PR-positive
    55
        one of both positive
    96
        no data
    1
    TNM stage (sono)
    Units: Subjects
        T1N0M0
    4
        T1N1M0
    9
        T2N0M0
    28
        T2N1M0
    68
        T2N2M0
    2
        T2N3M0
    2
        T3N0M0
    5
        T3N1M0
    9
        T4N0M0
    11
        T4N1M0
    12
        T4N2M0
    1
        no data
    1
    menopause
    Units: Subjects
        yes
    85
        no
    66
        not available
    1
    Body Surface Area
    Units: m²
        arithmetic mean (standard deviation)
    1.81 ± 0.19
    BMI
    Units: kg/m²
        arithmetic mean (standard deviation)
    28.3 ± 6.0
    tumor size (sono)
    Units: mm²
        arithmetic mean (standard deviation)
    1459 ± 6837

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Study arm
    Reporting group description
    		 Chemotherapy combination of Docetaxel, Epirubicine and Cyclophosphamide with breast preserving surgery
    Reporting group title
    Follow-up
    Reporting group description
    		 5 years Follow-up after study treatment

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Since this study was one-armed, the overall description of all patients is the only useful information

    Primary: pCR b inv

    		 Close Top of page
    End point title
    		 pCR b inv [1]
    End point description
    no mircoscopic findings of vital invasive tumor cells in resected tissues post surgery; in breast only, lymph nodes not considered
    End point type
    Primary
    End point timeframe
    assessed after all cycles of TEC regimen applied and the following 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: Due to the single-armed design no statistical analysis but the interval estimate of the end points (primary and secondary) are provided.
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        complete remission
    49
        incomplete remission
    103
    Attachments
    		 Untitled (Filename: DRKS-Meldg_NeoTEC-1armig.pdf)
    No statistical analyses for this end point

    Secondary: pCR inv

    		 Close Top of page
    End point title
    		 pCR inv
    End point description
    neither in breast nor in axillary lymphnodes invasive rests of tumor; results of pathology; patients with premature EoT did not reach CR
    End point type
    Secondary
    End point timeframe
    after all cycles of TEC and surgery (if applicable) = end of treatment
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        premature EoT
    4
        no rests
    40
        rests
    108
    No statistical analyses for this end point

    Secondary: pCR

    		 Close Top of page
    End point title
    		 pCR
    End point description
    neither invasive nor noninvasie rests of tumor (results of pathology)
    End point type
    Secondary
    End point timeframe
    after EoT
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        premature EoT
    4
        no rests
    34
        rests
    114
    No statistical analyses for this end point

    Secondary: cCR

    		 Close Top of page
    End point title
    		 cCR
    End point description
    clinical response
    End point type
    Secondary
    End point timeframe
    after EoT
    End point values
    		 FAS
    Number of subjects analysed
    150 [2]
    Units: subjects
        complete remission
    25
        partial remission
    99
        minimal response
    9
        no change
    7
        progressive disease
    5
        premature EoT
    5
    Notes
    [2] - no data in 2 patients
    No statistical analyses for this end point

    Secondary: Regression grade (Sinn 1994)

    		 Close Top of page
    End point title
    		 Regression grade (Sinn 1994)
    End point description
    acc. to Sinn HP et al. Geburtshilfe und Frauenheilkunde 1994:54; 552-558.
    End point type
    Secondary
    End point timeframe
    after EoT
    End point values
    		 FAS
    Number of subjects analysed
    148
    Units: subjects
        grade 3/4
    43
        grade<3
    105
    No statistical analyses for this end point

    Secondary: EFS

    		 Close Top of page
    End point title
    		 EFS
    End point description
    End point type
    Secondary
    End point timeframe
    until the end of Study (60 months of FUP)
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        no event
    110
        relapse/ metastasis/ death
    42
    No statistical analyses for this end point

    Secondary: OS

    		 Close Top of page
    End point title
    		 OS
    End point description
    End point type
    Secondary
    End point timeframe
    until EoS (60 months of FUP)
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        survived
    125
        deceased
    27
    No statistical analyses for this end point

    Secondary: breast-preserving surgery

    		 Close Top of page
    End point title
    		 breast-preserving surgery
    End point description
    End point type
    Secondary
    End point timeframe
    after EoT
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        yes
    107
        no
    41
        premature EoT w/o surgery
    4
    No statistical analyses for this end point

    Secondary: Treatment-associated toxicity of WHO grade >2

    		 Close Top of page
    End point title
    		 Treatment-associated toxicity of WHO grade >2
    End point description
    End point type
    Secondary
    End point timeframe
    until the end of (S)AE reporting period
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        Yes
    110
        No
    42
    No statistical analyses for this end point

    Secondary: SAE occurred

    		 Close Top of page
    End point title
    		 SAE occurred
    End point description
    End point type
    Secondary
    End point timeframe
    until the end of (S)AE reporting period
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        yes
    28
        no
    124
    No statistical analyses for this end point

    Other pre-specified: tox-associated premature EoT

    		 Close Top of page
    End point title
    		 tox-associated premature EoT
    End point description
    End point type
    Other pre-specified
    End point timeframe
    during chemotherapy (max. 6 cycles)
    End point values
    		 FAS
    Number of subjects analysed
    152
    Units: subjects
        Yes
    6
        no
    146
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first chemotherapy cycle up to 8 weeks after Administration of the last neoadjuvant chemotherapy cycle
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 This set of patients is identical to the FAS. The number of death refers to the entire period of observation (see sEP overall survival).

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 152 (18.42%)
         number of deaths (all causes)
    27
         number of deaths resulting from adverse events
    2
    Vascular disorders
    Subclavian vein thrombosis
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pyrexia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiomyopathy
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Anaemia
         subjects affected / exposed
    5 / 152 (3.29%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 152 (1.97%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Granulocytopenia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    11 / 152 (7.24%)
         occurrences causally related to treatment / all
    20 / 20
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    7 / 152 (4.61%)
         occurrences causally related to treatment / all
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    4 / 152 (2.63%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    4 / 152 (2.63%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    6 / 152 (3.95%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 152 (2.63%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Bone pain
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    3 / 152 (1.97%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 152 (1.32%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 152 (0.66%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    110 / 152 (72.37%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    6 / 152 (3.95%)
         occurrences all number
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    7 / 152 (4.61%)
         occurrences all number
    9
    Granulocytopenia
         subjects affected / exposed
    40 / 152 (26.32%)
         occurrences all number
    113
    Leukopenia
         subjects affected / exposed
    64 / 152 (42.11%)
         occurrences all number
    202
    Thrombocytopenia
         subjects affected / exposed
    8 / 152 (5.26%)
         occurrences all number
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 152 (7.24%)
         occurrences all number
    20
    Mucosal inflammation
         subjects affected / exposed
    7 / 152 (4.61%)
         occurrences all number
    15
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    4 / 152 (2.63%)
         occurrences all number
    9
    Nausea
         subjects affected / exposed
    7 / 152 (4.61%)
         occurrences all number
    9
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    35 / 152 (23.03%)
         occurrences all number
    114

    More information

    		 Close Top of page

    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
    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.

    European Medicines Agency © 1995-Sat May 04 21:18:19 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA