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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2016-004362-26
    Sponsor's Protocol Code Number:I3Y-MC-JPCF
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-07-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2016-004362-26
    A.3Full title of the trial
    A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
    Estudio en fase 3 aleatorizado, abierto, de abemaciclib en combinación con tratamiento endocrino adyuvante estándar frente a monoterapia con tratamiento endocrino adyuvante estándar, en pacientes con cáncer de mama en estadios iniciales, de alto riesgo, con afectación ganglionar, receptores hormonales positivos, HER2 negativo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare treatment after surgery of abemaciclib combined with standard endocrine therapy versus endocrine therapy alone in patients with early stage breast cancer
    Estudio en el que se comparará el tratamiento posquirúrgico con abemaciclib en combinación con el tratamiento endocrino estándar frente al tratamiento endocrino en monoterapia, en pacientes con cáncer de mama en estadios iniciales.
    A.3.2Name or abbreviated title of the trial where available
    MonarchE
    A.4.1Sponsor's protocol code numberI3Y-MC-JPCF
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLilly S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLilly S.A.
    B.5.2Functional name of contact pointAna Isabel Almansa
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de la Industria, 30
    B.5.3.2Town/ cityAlcobendas (Madrid)
    B.5.3.3Post code28108
    B.5.3.4CountrySpain
    B.5.4Telephone number003491663 34 55
    B.5.5Fax number003491663 34 81
    B.5.6E-mailalmasa_ana_isabel@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameabemaciclib
    D.3.2Product code LY2835219
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNabemaciclib
    D.3.9.2Current sponsor codeLY2835219
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameabemaciclib
    D.3.2Product code LY2835219
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNabemaciclib
    D.3.9.2Current sponsor codeLY2835219
    D.3.9.3Other descriptive nameABEMACICLIB
    D.3.9.4EV Substance CodeSUB171907
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
    Cáncer de mama con afectación de los ganglios linfáticos, estadios iniciales, receptores hormonales positivos y que no expresa receptores de tipo 2 del factor de crecimiento epidérmico humano.
    E.1.1.1Medical condition in easily understood language
    Breast Cancer
    Cáncer de mama
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006199
    E.1.2Term Breast cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare invasive disease free survival (IDFS) for patients receiving adjuvant endocrine therapy plus abemaciclib treatment versus adjuvant endocrine therapy alone in HR+, HER2- breast cancer.
    Comparar la supervivencia sin enfermedad invasiva (SSEI) cuando se administra un tratamiento endocrino adyuvante y abemaciclib o un tratamiento endocrino adyuvante en monoterapia, en pacientes con cáncer de mama HR+ y HER2-.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, in terms of IDFS, for patients with Ki67 index ≥20% by central lab
    To evaluate the efficacy in terms of distant relapse-free survival (DRFS) and overall survival (OS)
    To assess the safety profile
    To evaluate the relationship between abemaciclib exposure and clinical (efficacy and safety) outcomes
    To evaluate health status, general oncology and breast cancer self-reported health related quality of life
    • Evaluar la eficacia, desde el punto de vista de la SSEI, en pacientes con un índice Ki67 ≥ 20 % (determinado en el laboratorio central).
    • Evaluar la eficacia, desde el punto de vista de la supervivencia sin metástasis (SSM) y la supervivencia global (SG).
    • Evaluar el perfil de seguridad.
    • Evaluar la relación entre la exposición a abemaciclib y los resultados clínicos (eficacia y seguridad).
    • Evaluar la calidad de vida relacionada con la salud percibida por el paciente (tanto en relación con el cáncer de mama como desde un punto de vista oncológico general).
    • Evaluar el estado de salud para tomar decisiones fundamentadas sobre modelos para la evaluación de economía sanitaria, utilizando el cuestionario EuroQol de cinco dimensiones y cinco niveles (EQ-5D-5L).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Female or male ≥18 years of age
    •The patient has confirmed HR+, HER2-negative (HER2-), early stage resected invasive breast cancer without evidence of distant metastases.
    •The patient must have undergone definitive surgical treatment for the current malignancy.
    •The patient must have tumor tissue for biomarker analysis available prior to randomization.
    •The patient must have high risk of disease recurrence based on nodal status, tumor size, or grade regardless of Ki67 status (Cohort 1), or eligible exclusively based on a Ki67 status (Cohort 2)
    •The patient must be randomized within 12 weeks of completion of last non endocrine treatment
    •If the patient is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 8 weeks prior to randomization.
    •Women regardless of menopausal status.
    •Women of reproductive potential must have a negative serum pregnancy and agree to use highly effective contraceptive methods
    •The patient has a ECOG performance status ≤1
    • Pacientes de ambos sexos y al menos 18 años.
    • Diagnóstico confirmado de cáncer de mama reseccionado, invasivo, HR+, HER2 negativo (HER2-), en estadios iniciales, sin signos de metástasis a distancia.
    • El paciente debe haberse sometido a un tratamiento quirúrgico definitivo para la neoplasia maligna actual.
    • Debe contarse con tejido tumoral para realizar análisis de biomarcadores antes de la aleatorización.
    • Presentar alto riesgo de recidiva del cáncer, en función de la afectación ganglionar, el tamaño o el grado del tumor (independientemente de la expresión del Ki67) (cohorte 1) o considerarse idóneo de acuerdo exclusivamente con la expresión del Ki67 (cohorte 2).
    • La aleatorización debe realizarse en el transcurso de las 12 semanas posteriores a la finalización del último tratamiento no endocrino.
    • Si el paciente recibe en la actualidad o comienza a recibir tratamiento endocrino adyuvante estándar en el momento de la inclusión en el estudio, no debe haber recibido este tratamiento durante más de 8 semanas antes de la aleatorización.
    • El paciente debe haberse recuperado de los efectos inmediatos de la quimioterapia y la radioterapia, y de los efectos secundarios de la intervención quirúrgica definitiva del cáncer de mama.
    • Las mujeres podrán participar, independientemente del estado menopáusico.
    • Las mujeres fértiles deben presentar un resultado negativo en una prueba de embarazo en suero y estar de acuerdo en utilizar métodos anticonceptivos muy eficaces.
    • Presentar una categoría funcional ECOG ≤1.
    • Presentar una función orgánica aceptable.
    • Ser capaz de ingerir medicamentos por vía oral.
    • Haber otorgado el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    •The patient has Stage IV (M1), Stage IA, and lymph node-negative breast cancer
    •The patient has a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years.
    •Females who are pregnant or lactating
    •The patient has previously received treatment with any CDK4 and CDK6 inhibitor.
    •The patient is receiving concurrent exogenous hormone therapy (for example, birth control pills or hormone replacement therapy).
    •The patient has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
    • Presentar cáncer de mama en estadio IV (M1), estadio IA y sin afectación ganglionar.
    • Antecedentes de cualquier otro cáncer (excepto cáncer de piel no melanomatoso o carcinoma in situ de cuello uterino), salvo que haya estado en remisión completa al menos durante 5 años, sin ningún tipo de tratamiento.
    • Pacientes embarazadas o en período de lactancia.
    • Haber recibido anteriormente tratamiento con cualquier inhibidor de la CDK4 o la CDK6.
    • Estar recibiendo en la actualidad hormonoterapia exógena (por ejemplo, anticonceptivos orales u hormonoterapia de reposición).
    • Haber recibido anteriormente tratamiento endocrino para prevenir el cáncer de mama (tamoxifeno, raloxifeno o inhibidores de la aromatasa).
    • Presentar enfermedades preexistentes graves que, en opinión del investigador, podrían impedir su participación en este estudio.
    • Antecedentes personales de cualquiera de las enfermedades siguientes: síncope de causa cardiovascular, arritmia ventricular de origen patológico o paro cardiaco súbito.
    • Presentar infección bacteriana activa (que requiera la administración de antibióticos por vía intravenosa [i.v.] al inicio del tratamiento del estudio), micosis o infección vírica detectable.
    • Haberse sometido a una intervención quirúrgica en el transcurso de los 14 días anteriores a la aleatorización.
    • Haber recibido un tratamiento experimental en un ensayo clínico en el transcurso de los 30 días (o 5 semividas, el período de tiempo más prolongado) anteriores a la aleatorización o participar en la actualidad en cualquier otro tipo de investigación médica (por ejemplo, de un producto sanitario) que se considere incompatible con el estudio desde un punto de vista científico o médico.
    E.5 End points
    E.5.1Primary end point(s)
    To compare invasive disease free survival (IDFS) for patients receiving adjuvant endocrine therapy plus abemaciclib treatment versus adjuvant endocrine therapy alone in HR+, HER2- breast cancer.
    Comparar la supervivencia sin enfermedad invasiva (SSEI) cuando se administra un tratamiento endocrino adyuvante y abemaciclib o un tratamiento endocrino adyuvante en monoterapia, en pacientes con cáncer de mama HR+ y HER2-.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After approximately 5 years when approximately 345 events have occured.
    Una vez que hayan transcurrido aproximadamente 5 años, cuando se hayan producido aproximadamente 345 eventos.
    E.5.2Secondary end point(s)
    •Primary: invasive disease-free survival (IDFS) as defined by the STEEP System (Hudis et al. 2007)
    •Efficacy endpoints: distant relapse-free survival (DRFS), overall survival (OS)
    •Safety endpoints will include but are not limited to the following: TEAEs, SAEs, and hospitalizations Clinical laboratory tests, vital signs, and physical examinations
    •Steady-state trough abemaciclib concentration (Cmin,ss), hazard ratio for IDFS, DRFS, OS, other efficacy and safety endpoints
    •Composite and single-item endpoints will be evaluated to examine differentiating effects of abemaciclib across study arms. Measurement will be undertaken using the FACT-B questionnaire for general oncology and breast cancer health-related quality of life; the FACT-ES subscale and additional FACIT-sourced items for cognitive and bladder endocrine therapy symptoms; and the FACIT-F subscale to characterize this symptom know to be associated with oncology, endocrine therapy, and abemaciclib treatment.
    •The EQ-5D-5L health state profile (the index score and the single-item health status measure) will be used to inform decision modeling for economic evaluations and this questionnaire will be coadministered with and after first completing the FACT/FACIT questionnaire, subscales, and additional items.
    • Principal: supervivencia sin enfermedad invasiva (SSEI), de acuerdo con el sistema STEEP (Hudis et al. 2007).
    • Criterios de valoración de la eficacia: supervivencia sin metástasis (SSM), supervivencia global (SG).
    • Los criterios de valoración de la seguridad incluirán, entre otros: AAST, AAG, hospitalizaciones, análisis clínicos, constantes vitales y exploraciones físicas.
    • Concentración mínima de abemaciclib en equilibrio (Cmín,ee), cociente de riesgos instantáneos para la SSEI, la SSM, la SG y otros criterios de valoración de la eficacia y la seguridad.
    • Se evaluarán criterios de valoración compuestos y únicos para determinar los efectos diferenciadores de abemaciclib en los grupos de tratamiento. La calidad de vida relacionada con la salud (tanto en relación con el cáncer de mama como desde un punto de vista oncológico general) se determinará mediante el cuestionario FACT-B; los síntomas cognitivos y los síntomas relacionados con la vejiga y el tratamiento endocrino, con la subescala FACT-ES e ítems de la escala FACIT; y los síntomas que se sabe que están asociados con el tratamiento oncológico, endocrino y abemaciclib, mediante la subescala FACIT-F.
    • El perfil del estado de salud de acuerdo con el cuestionario EQ-5D-5L (la puntuación de referencia y la medida del estado de salud [ítem único]) se utilizará para tomar decisiones fundamentadas sobre modelos para la evaluación económica. Este cuestionario se contestará después de cumplimentar los cuestionarios FACT/FACIT, las subescalas y los ítems adicionales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After approximately 5 years when approximately 345 events have occured.
    At the end of trial.
    Una vez que hayan transcurrido aproximadamente 5 años, cuando se hayan producido aproximadamente 345 eventos. Al final del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA181
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hong Kong
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Saudi Arabia
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1790
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1790
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state154
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1416
    F.4.2.2In the whole clinical trial 3580
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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