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    Clinical Trial Results:
    An Open-Label, Multicentre, Single-Arm Study to Characterise the Efficacy, Safety, and Tolerability of Gefitinib 250 mg (IRESSA™1) as First-Line Treatment in Caucasian Patients Who Have Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    2010-018614-70
    Trial protocol
    PT   ES   GB   FR   IT   NO   HU   GR   BG  
    Global end of trial date
    06 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Jun 2017
    First version publication date
    10 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D791AC00014
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    One Medimmune Way, 101 ORD, 2233C, Gaithersburg, United States, MD 20878
    Public contact
    Yuri Rukazenkov, AstraZeneca, +44 01625 231825, yuri.rukazenkov@astrazeneca.com
    Scientific contact
    Yuri Rukazenkov, AstraZeneca, +44 01625 231825, yuri.rukazenkov@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Aug 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Aug 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the ORR (confirmed complete response [CR] or partial response [PR]) of gefitinib using Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, in Caucasian patients with Activating sensitising EGFR mutation-positive (EGFR M+) Non-small cell lung cancer (NSCLC).
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    This was a single arm trial - there were no comparators
    Actual start date of recruitment
    08 Sep 2010
    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
    Bulgaria: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Hungary: 20
    Country: Number of subjects enrolled
    Italy: 5
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Portugal: 7
    Country: Number of subjects enrolled
    Romania: 19
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Turkey: 7
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Poland: 12
    Worldwide total number of subjects
    107
    EEA total number of subjects
    99
    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)
    53
    From 65 to 84 years
    54
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    1060 Caucasian patients with locally advanced or metastatic NSCLC were screened, and 118 patients had activating sensitizing EGFR mutation eligible for the study (EGFR M+). 107 patients received at least 1 dose of gefitinib: 106 were EGFR M+ and one EGFR M+I (ineligible).

    Pre-assignment
    Screening details
    1060 Caucasian patients with locally advanced or metastatic NSCLC were screened, and 118 patients had activating sensitizing EGFR mutation eligible for the study (EGFR M+). 107 patients received at least 1 dose of gefitinib: 106 were EGFR M+ and one EGFR M+I (ineligible).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Gefitinib
    Arm description
    Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
    Arm type
    Experimental

    Investigational medicinal product name
    Iressa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    250mg tablet once daily

    Number of subjects in period 1
    Gefitinib
    Started
    107
    Completed
    71
    Not completed
    36
         Adverse event, serious fatal
    29
         Due to objective disease progression
    1
         Consent withdrawn by subject
    3
         Due to EGFR M+I patient
    1
         Lost to follow-up
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gefitinib
    Reporting group description
    Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.

    Reporting group values
    Gefitinib Total
    Number of subjects
    107 107
    Age categorical
    Units: Subjects
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    53 53
        From 65-84 years
    54 54
        85 years and over
    0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    63.8 ± 12 -
    Gender, Male/Female
    Units: Participants
        Female
    76 76
        Male
    31 31
    Race/Ethnicity, Customized
    Units: Subjects
        White
    107 107
    Age, Customized
    Units: Subjects
        >=18 to <65 years
    53 53
        >=65 to <75 years
    28 28
        >=75 years
    26 26

    End points

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    End points reporting groups
    Reporting group title
    Gefitinib
    Reporting group description
    Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.

    Primary: Objective response rate (ORR) (Investigator)

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    End point title
    Objective response rate (ORR) (Investigator) [1]
    End point description
    % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements made at site by investigator.
    End point type
    Primary
    End point timeframe
    Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: This is a single arm study with no planned comparative analysis and so non is included in this form
    End point values
    Gefitinib
    Number of subjects analysed
    106 [2]
    Units: Percentage of Participants
    number (confidence interval 95%)
        % Responders
    69.8 (60.5 to 77.7)
    Notes
    [2] - One subject excluded from analysis as not eligible for study
    No statistical analyses for this end point

    Secondary: Disease Control Rate (DCR) (Investigator)

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    End point title
    Disease Control Rate (DCR) (Investigator)
    End point description
    DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements made at site by investigator.
    End point type
    Secondary
    End point timeframe
    Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months
    End point values
    Gefitinib
    Number of subjects analysed
    106 [3]
    Units: Percentage of Participants
    number (confidence interval 95%)
        % Controlled
    90.6 (83.5 to 94.8)
    Notes
    [3] - One subject excluded from analysis as not eligible for study.
    No statistical analyses for this end point

    Secondary: Progression - Free Survival (PFS) (Investigator)

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    End point title
    Progression - Free Survival (PFS) (Investigator)
    End point description
    PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements made at site by investigator.
    End point type
    Secondary
    End point timeframe
    Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months
    End point values
    Gefitinib
    Number of subjects analysed
    106 [4]
    Units: Months
        median (confidence interval 95%)
    9.72 (8.48 to 11.04)
    Notes
    [4] - One subject excluded from analysis as not eligible for study.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    Overall Survival (OS)
    End point description
    OS was defined as the time from first dose of gefitinib study treatment until death by any cause. Patients who had not died at the time of analysis were censored at the last date the patient was known to be alive.
    End point type
    Secondary
    End point timeframe
    Survival follow up from first dose of gefitinib till death of the patient or till end of study in absence of death.
    End point values
    Gefitinib
    Number of subjects analysed
    106 [5]
    Units: Months
        median (confidence interval 95%)
    19.22 (16.95 to 99999999999)
    Notes
    [5] - NB Upper limit of confidence interval for Median is Not Calculable due to insufficient data.
    No statistical analyses for this end point

    Other pre-specified: Disease Control Rate (DCR) (Independent central review)

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    End point title
    Disease Control Rate (DCR) (Independent central review)
    End point description
    DCR is calculated as the % of the FAS patient population with a best visit response of CR, PR (a visit response of CR or PR which is confirmed at least 4 weeks later) or stable disease (SD). SD is defined as no evidence of CR, PR or progression and must have occurred at a minimum of 6 weeks after first dose of study treatment. (progression is defined as ≥20% increase in the sum of the diameters of target lesions from minimum; clinically significant progression in non-target lesions; the presence of a new lesion or death). Outcome is based on measurements of scans by central review.
    End point type
    Other pre-specified
    End point timeframe
    Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months
    End point values
    Gefitinib
    Number of subjects analysed
    106 [6]
    Units: Percentage of Participants
    number (confidence interval 95%)
        % Controlled
    88.7 (81.2 to 93.4)
    Notes
    [6] - One subject excluded from analysis as not eligible for study.
    No statistical analyses for this end point

    Other pre-specified: Objective response rate (ORR) (Independent central review))

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    End point title
    Objective response rate (ORR) (Independent central review))
    End point description
    % of patients in the Full analysis set who have a complete response [CR] or partial response [PR] confirmed by repeat imaging at least 4 weeks later with no evidence of progression between confirmation visits (as defined by Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1)). CR: disappearance of all target lesions (TLs) & non-target lesions (NTLs). PR: >= 30% decrease in the sum of diameters compared to baseline (with no evidence of progression) and the NTLs are at least stable with no evidence of new lesions. Outcome is based on measurements of scans by central review.
    End point type
    Other pre-specified
    End point timeframe
    Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months
    End point values
    Gefitinib
    Number of subjects analysed
    106 [7]
    Units: Percentage of Participants
    number (confidence interval 95%)
        % Responders
    50 (40.6 to 59.4)
    Notes
    [7] - One subject excluded from analysis as not eligible for study.
    No statistical analyses for this end point

    Other pre-specified: Progression - Free Survival (PFS) (Independent central review)

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    End point title
    Progression - Free Survival (PFS) (Independent central review)
    End point description
    PFS was defined as the time from the first dose of gefitinib study treatment until objective disease progression as defined by RECIST 1.1 (≥20% increase in the sum of the diameters of target lesions from minimum, clinically significant progression in non-target lesions or the presence of a new lesion) or death (by any cause in the absence of progression). Progression is based on measurements of scans by central review.
    End point type
    Other pre-specified
    End point timeframe
    Scans taken at baseline and then follow up assessments taken every 6 weeks until progression, or last evaluable assessment in the absence of progression, assessed up to 23 months
    End point values
    Gefitinib
    Number of subjects analysed
    106 [8]
    Units: Months
        median (confidence interval 95%)
    6.97 (6.41 to 9.86)
    Notes
    [8] - One subject excluded from analysis as not eligible for study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events and Serious Adverse Events were collected from the time of screening informed consent throughout the treatment period, until 30 days after discontinuation of gefitinib treatment. All ongoing AEs & SAEs were to be followed until resolution.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15
    Reporting groups
    Reporting group title
    Gefitinib 250 mg
    Reporting group description
    -

    Serious adverse events
    Gefitinib 250 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 107 (19.63%)
         number of deaths (all causes)
    29
         number of deaths resulting from adverse events
    0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RADIUS FRACTURE
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TIBIA FRACTURE
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    CARDIAC FAILURE
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Respiratory, thoracic and mediastinal disorders
    HAEMOPTYSIS
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    DEMENTIA ALZHEIMER'S TYPE
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    HYPOAESTHESIA
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SENILE DEMENTIA
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    VOMITING
         subjects affected / exposed
    3 / 107 (2.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    SKIN NECROSIS
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    GASTROENTERITIS
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    3 / 107 (2.80%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    VIRAL INFECTION
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Gefitinib 250 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    87 / 107 (81.31%)
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    6
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    9 / 107 (8.41%)
         occurrences all number
    10
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    7 / 107 (6.54%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    12 / 107 (11.21%)
         occurrences all number
    12
    DYSPNOEA
         subjects affected / exposed
    7 / 107 (6.54%)
         occurrences all number
    7
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    6
    General disorders and administration site conditions
    ASTHENIA
         subjects affected / exposed
    12 / 107 (11.21%)
         occurrences all number
    12
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    31 / 107 (28.97%)
         occurrences all number
    55
    NAUSEA
         subjects affected / exposed
    11 / 107 (10.28%)
         occurrences all number
    14
    VOMITING
         subjects affected / exposed
    12 / 107 (11.21%)
         occurrences all number
    13
    Skin and subcutaneous tissue disorders
    DRY SKIN
         subjects affected / exposed
    12 / 107 (11.21%)
         occurrences all number
    13
    DERMATITIS ACNEIFORM
         subjects affected / exposed
    7 / 107 (6.54%)
         occurrences all number
    7
    RASH
         subjects affected / exposed
    50 / 107 (46.73%)
         occurrences all number
    65
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    10 / 107 (9.35%)
         occurrences all number
    11
    Infections and infestations
    URINARY TRACT INFECTION
         subjects affected / exposed
    7 / 107 (6.54%)
         occurrences all number
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2011
    The amendment included the following updates to the protocol: - Final IPASS OS analysis had been conducted and new data were added to the CSP. -New safety information regarding gastrointestinal perforation reported in patients taking IRESSA, in most cases this was associated with other known risk factors, including increasing age, concomitant medications such as steroids or NSAIDS, underlying history of GI ulceration, smoking or bowel metastases at sites of perforation. -Clarification of exclusion criteria no 3, that patients considered to require radiotherapy to the lung at the time of study entry or in the near future are excluded from the study. -Clarification that residual material (tumour) may be used for optional exploratory biomarker research if consent has been obtained for this research. -Clarification that Residual material (tumour, plasma, serum) will be stored for a maximum of 25 years. -Clarification that for each of the following objectives: ORR, DCR, PFS and OS, the mutation sub type of the positive mutations will be considered as subgroups.

    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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