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    Summary
    EudraCT Number:2015-000662-65
    Sponsor's Protocol Code Number:D5164C00001
    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:2015-08-20
    Trial 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 number2015-000662-65
    A.3Full title of the trial
    A Phase III, double-blind, randomized, placebo-controlled multi-centre, study to assess the efficacy and safety of AZD9291 versus Placebo, in patients with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy (ADAURA)
    Estudio de Fase III, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de AZD9291 frente a placebo en pacientes con carcinoma de pulmón no microcítico con mutación del receptor del factor de crecimiento epidérmico, en Estadio IB-IIIA, tras la resección completa del tumor, con o sin quimioterapia adyuvante (ADAURA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A late stage clinical trial to investigate the efficacy and safety of AZD9291 versus Placebo in patients with stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy
    Estudio de fase avanzada para investigar la eficacia y la seguridad de AZD9291 frente a placebo en pacientes con carcinoma de pulmón no microcítico en estadio IB-IIIA tras la resección completa del tumor con o sin quimioterapia adyuvante
    A.3.2Name or abbreviated title of the trial where available
    ADAURA
    ADAURA
    A.4.1Sponsor's protocol code numberD5164C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressUSA
    B.5.3.2Town/ cityUSA
    B.5.3.3Post codeUSA
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34913913443
    B.5.6E-mailinformation.centre@astrazeneca.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 nameAZD9291 80 mg film-coated tablet
    D.3.2Product code AZD9291
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot yet assigned
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 nameAZD9291 40 mg film-coated tablet
    D.3.2Product code AZD9291
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot yet assigned
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Stage IB-IIIA non-small cell lung carcinoma, with a centrally confirmed, common sensitising EGFR mutations (Ex19del and L858R either alone or in combination with other EGFR mutations), following complete tumour resection with or without adjuvant chemotherapy
    Carcinoma de pulmón no microcítico en Estadio IB-IIIA, con las mutaciones sensibilizantes del EGFR más comunes (Ex19del y L858R ya sea sola o en combinación con otras mutaciones del EGFR), confirmadas de manera centralizada, tras la resección completa del tumor, con o sin quimioterapia adyuvante
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "non-small cell lung cancer" (NSCLC) stage IB-IIIA with EGFR mutations positive
    Tipo específico de cancer de pulmón llamado "cáncer de pulmón no microcítico" (CPNM) estadio IB-IIIA con mutaciones EGFR positivas
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    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 assess the efficacy of AZD9291 compared to placebo as measured by disease free survival (DFS)
    Evaluar la eficacia de AZD9291 en comparación con placebo mediante la medición de la supervivencia sin enfermedad (SSE)
    E.2.2Secondary objectives of the trial
    1) To further assess the efficacy of AZD9291 compared with placebo by assessment of DFS rate at 2 years, 3 years and 5 years, of OS and OS rate at 5 years
    2) To assess the effect of AZD9291 compared with placebo on health-related quality of life (HRQoL) by assessment of patient health-related quality of life and symptoms (HRQoL) using SF-36 questionnaire (version 2)
    3) To characterise the pharmacokinetics (PK) of AZD9291 and its metabolites (AZ5104 and AZ7550) by assessment of PK exposure parameters derived from plasma concentrations of AZD9291 and metabolites AZ5104 and AZ7550.
    4) To assess the safety and tolerability profile of AZD9291 compared with placebo by assessment of number and severity of adverse events, clinical chemistry, haematology, urinalysis, vital signs, physical examination, body weight, digital electrocardiogram (ECG), left Ventricular Ejection Fraction (LVEF), World Health Organization (WHO) Performance Status and Ophthalmologic assessment
    1) Evaluar adicionalmente la eficacia del tratamiento con AZD9291 en comparación con placebo mediante evaluación de la SSE a los 2, 3 y 5 años, de la Supervivencia global (SG) y SG a los 5 años.
    2) Evaluar el efecto de AZD9291 en comparación con placebo sobre la calidad de vida relacionada con la salud (HRQoL) mediante la medición del HRQoL de los pacientes a través del cuestionario SF-36 (version 2)
    3) Caracterizar la farmacocinética (FC) de AZD9291 y sus metabolitos (AZ5104 y AZ7550) mediante evaluación de los parámetros de exposición derivados de las concentraciones plasmáticas de AZD9291 y sus metabolitos AZ5104 y AZ7550.
    4) Evaluar el perfil de seguridad y de tolerabilidad del tratamiento con AZD9291 en comparación con placebo mediante la evaluación del número y gravedad de acontecimientos adversos, bioquímica sérica, hematología, análisis de orina, constantes vitales, exploración física, peso corporal, ECG digital , FEVI, Estado funcional de la OMS, y Estudio oftalmológico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged at least 18 years.
    2. Histologically confirmed diagnosis of primary non small lung cancer (NSCLC) on predominantly non-squamous histology
    3. MRI or CT scan of the brain must be done prior to surgery as it is considered standard of care.
    4. Patients must be classified post-operatively as Stage IB, II or IIIA on the basis of pathologic criteria.
    5. Confirmation by the central laboratory that the tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including T790M.
    6. Complete surgical resection of the primary NSCLC is mandatory. All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
    7. Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
    8. World Health Organization Performance Status of 0 to 1.
    9. Female patients should be using adequate contraceptive measures, should not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-child-bearing potential.
    1. Hombre o mujer, de como mínimo 18 años de edad.
    2. Diagnóstico, confirmado histológicamente, de cáncer de pulmón no microcítico (CPNM) primario de histología predominantemente no epidermoide
    3. Antes de la cirugía deberá haberse practicado una RM o un TAC de cerebro, al tratarse de una práctica habitual.
    4. Posoperatoriamente, los pacientes deberán clasificarse como en estadio IB, II o IIIA según criterios anatomopatológicos.
    5. Confirmación por el laboratorio central de que el tumor es portador de una de las 2 mutaciones más frecuentes del EGFR que se sabe que se asocian a sensibilidad de la tirosina cinasa del EGFR (Ex19del, L858R), ya sea sola o en combinación con otras mutaciones del EGFR, incluida la mutación T790M.
    6. Es imprescindible la resección quirúrgica completa del CPNM primario. Al término de la cirugía deberá haberse resecado toda la enfermedad macroscópica. Todos los márgenes quirúrgicos de la resección deben estar libres de enfermedad.
    7. En ocasión de la aleatorización, recuperación completa de la cirugía y del tratamiento posoperatorio estándar (si procede).
    8. Estado funcional de la OMS 0 o 1.
    9. Las pacientes de sexo femenino deberán utilizar medidas anticonceptivas adecuadas, no podrán estar practicando la lactancia natural y deberán presentar un resultado negativo en una prueba de embarazo antes de la primera dosis del fármaco del estudio; o las pacientes de sexo femenino debén presentar evidencia de carecer de potencial procreativo.
    E.4Principal exclusion criteria
    1. Treatment with any of the following:
    - Pre-operative or post-operative or planned radiation therapy for the current lung cancer
    - Pre-operative (neo-adjuvant) platinum based or other chemotherapy
    - Any prior anticancer therapy
    - Prior treatment with neoadjuvant or adjuvant EGFR-TKI at any time
    - Major surgery (including primary tumour surgery, excluding placement of vascular access within 4 weeks of the first dose of study drug
    - Patients currently receiving medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 and potent inducers of CYP3A4
    - Treatment with an investigational drug within five half-lives of the compound or any of its related material.
    2. Patients who have had only segmentectomies or wedge resections
    3. History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment.
    4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
    5. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9291.
    6. Any of the following cardiac criteria:
    - Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value.
    - Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval.
    7. Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
    8. Inadequate bone marrow reserve or organ-function.
    1. Cualquiera de los siguientes tratamientos:
    - Radioterapia preoperatoria o postoperatoria o programada para el cáncer de pulmón actual
    - Quimioterapia preoperatoria (neoadyuvante) basada en el platino o en otro fármaco
    - Cualquier tratamiento antineoplásico previo
    - Tratamiento previo neoadyuvante o adyuvante con un inhibidor de la tirosina cinasa del EGFR
    - Cirugía mayor (incluida la cirugía del tumor primario y excluida la colocación de un acceso vascular) en el plazo de las 4 semanas anteriores a la primera dosis del fármaco del estudio.
    - Pacientes que estén recibiendo actualmente medicamentos o suplementos de herbolario conocidos como potentes inhibidores de citocromo P450 (CIP)3A4 y potentes inductores de CYP3A4
    - Tratamiento con un fármaco en fase de investigación sin haber transcurrido cinco semividas de dicho producto o de cualquier material relacionado, si se conoce.
    2. Pacientes sometidos solamente a segmentectomía o resección en cuña
    3. Antecedentes de otro proceso maligno, excepto: cáncer cutáneo de tipo no melanoma tratado adecuadamente, cáncer in situ tratado curativamente u otros tumores sólidos tratados curativamente y sin evidencia de enfermedad durante> 5 años después del fin del tratamiento.
    4. Toda evidencia de enfermedad sistémica severa o no controlada lo que incluye la hipertensión no controlada y las diátesis hemorrágicas activas; o infección activa, tal como hepatitis B, hepatitis C y virus de la inmunodeficiencia humana (VIH).
    5. Náuseas y vómitos resistentes al tratamiento, enfermedades gastrointestinales crónicas, incapacidad de deglutir el producto formulado o resección intestinal importante previa que pueda impedir la absorción adecuada de AZD9291.
    6. Cualquiera de los siguientes criterios cardíacos:
    - Valor medio del intervalo QT corregido (QTc) en reposo >470 ms, obtenido a partir de 3 ECG, utilizando el valor del QTcF calculado por el electrocardiógrafo del centro en la selección.
    - Cualquier factor que aumente el riesgo de prolongación del QTc o de arritmias, o muerte súbita inexplicada en un familiar de primer grado menor de 40 años, o cualquier medicamento concomitante que se sabe que prolonga el intervalo QT.
    7. Antecedentes médicos de neumopatía intersticial (NPI), NPI de origen farmacológico, neumonitis por radiación que haya precisado tratamiento con corticoides, o cualquier evidencia de NPI clínicamente activa
    8. Reserva de médula ósea o función orgánica inadecuadas.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (DFS) using investigator assessments
    Supervivencia sin enfermedad (SSE) según evaluación del Investigador
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline and from randomization until recurrence
    En el momento basal y desde la aleatorización hasta recurrencia.
    E.5.2Secondary end point(s)
    1) Assessment of Disease free survival (DFS) rate at 2 years, 3 years and 5 years
    2) Analysis of Overall Survival (OS)
    3) Assessment of Overall Survival (OS) rate at 5 years
    4) Assessing of patient health-related quality of life and symptoms (HRQoL) using SF-36 questionnaire (version 2, standard)
    5) PK exposure parameters derived from plasma concentrations of AZD9291 and metabolites AZ5104 and AZ7550.
    Pharmacokinetics data from this study will be analysed using a population PK approach and may also form part of a pooled analysis with other AZD9291 studies; results from these analyses will be reported separately from the CSR
    6) Safety and tolerability endpoints assessed by number and severity of adverse events, clinical chemistry, haematology, urinalysis, vital signs, physical examination, body weight, digital electrocardiogram (ECG), left Ventricular Ejection Fraction (LVEF), World Health Organization (WHO) Performance Status and Ophthalmologic assessment
    1) Evaluación de la SSE a los 2, 3 y 5 años
    2) Supervivencia global (SG)
    3) SG a los 5 años.
    4) Evaluación de la calidad de vida relacionada con la salud (HRQoL) usando el cuestionario SF-36 (versión 2)
    5) parámetros de exposición derivados de las concentraciones plasmáticas de AZD9291 y sus metabolitos AZ5104 y AZ7550.
    Los datos de FC de este estudio se analizarán mediante una estrategia de FC poblacional y podrán analizarse conjuntamente con los de otros estudios con AZD9291; los resultados de estos análisis se comunicarán por separado del Clinical Study Report (CSR).
    6) Perfil de seguridad y de tolerabilidad mediante la evaluación del número y gravedad de acontecimientos adversos, bioquímica sérica, hematología, análisis de orina, constantes vitales, exploración física, peso corporal, ECG digital , FEVI, Estado funcional de la OMS, y Estudio oftalmológico
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the trial
    A lo largo 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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    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
    Australia
    Belgium
    Brazil
    Canada
    China
    France
    Germany
    Hong Kong
    Hungary
    Israel
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    United States
    Vietnam
    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
    The last visit of the last patient undergoing the study
    Última visita del ultimo paciente en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days0
    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: 322
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 378
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 187
    F.4.2.2In the whole clinical trial 700
    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)
    Patients will be treated in accordance with the regional Standard of Care
    Los pacientes serán tratados de acuerdo a la práctica clínica habitual local
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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