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    Clinical Trial Results:
    A Phase II, Randomised, Double-blind, Parallel Group Study to Assess the Efficacy of Cediranib (AZD2171, RECENTIN) 45mg Versus Placebo following 12 Weeks of Treatment in Patients with Metastatic or Recurrent Renal Cell Carcinoma who have had no Previous Anti-VEGF Therapy

    Summary
    EudraCT number
    2006-002455-33
    Trial protocol
    NL   GB  
    Global end of trial date
    18 Oct 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    02 Nov 2017
    First version publication date
    02 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D8480C00030
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    132 Hills Road, Cambridge, United Kingdom, CB2 1PG
    Public contact
    Tsveta Milenkova, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Tsveta Milenkova, AstraZeneca, ClinicalTrialTransparency@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
    16 May 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 May 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the efficacy of cediranib compared to the efficacy of placebo in patients with metastatic or recurrent renal cell carcinoma by comparing changes in tumour size after 12 weeks of therapy (or upon progression if this occurs before 12 weeks).
    Protection of trial subjects
    If toxicity is encountered, the dose may be reduced (from 45mg to 30mg to 20mg) or treatment stopped until resolution of symptoms. At the discretion of the investigator, treatment may then be restarted. A maximum 14-day delay in dosing for cediranib is permitted. Only two dose level reductions will be allowed and re-escalations will not be permitted.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Jan 2007
    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
    United Kingdom: 79
    Country: Number of subjects enrolled
    Netherlands: 26
    Worldwide total number of subjects
    105
    EEA total number of subjects
    105
    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)
    64
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    n=53 (Cediranib 45mg) and n=18 (Placebo) for both the full analysis set (ITT), and the safety set.

    Pre-assignment
    Screening details
    105 patients enrolled. 53 were randomised to Cediranib 45mg, 18 to Placebo, and 34 not randomised. All patients randomised received at least one dose of assigned treatment.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cediranib 45mg
    Arm description
    Cediranib 45mg was be administered as a 30mg tablet and a 15mg tablet combination, taken orally once daily
    Arm type
    Experimental

    Investigational medicinal product name
    Cediranib
    Investigational medicinal product code
    AZD2171
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45mg once daily, administered as a 30mg tablet and a 15mg tablet combination.

    Arm title
    Placebo
    Arm description
    Cediranib placebo was be administered as a 30mg tablet and a 15mg tablet combination taken orally once daily.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    45mg once daily, administered as a 30mg tablet and a 15mg tablet combination.

    Number of subjects in period 1 [1]
    Cediranib 45mg Placebo
    Started
    53
    18
    Completed
    22
    4
    Not completed
    31
    14
         Death
             2
             1
         Other
             21
             6
         Incorrect enrolment/eligib criteria not fulfilled
             -
             1
         Adverse event, non-fatal
             6
             5
         Voluntary discontinuation by subject
             2
             1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Number enrolled is not the same as number randomised onto the study baseline period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cediranib 45mg
    Reporting group description
    Cediranib 45mg was be administered as a 30mg tablet and a 15mg tablet combination, taken orally once daily

    Reporting group title
    Placebo
    Reporting group description
    Cediranib placebo was be administered as a 30mg tablet and a 15mg tablet combination taken orally once daily.

    Reporting group values
    Cediranib 45mg Placebo Total
    Number of subjects
    53 18 71
    Age Categorical
    Units: Subjects
        ≥18 years to <65 years
    37 12 49
        ≥65 years to <75 years
    14 5 19
        ≥75 years
    2 1 3
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    60.7 ± 7.7 62.4 ± 8.7 -
    Gender Categorical
    Units: Subjects
        Female
    13 3 16
        Male
    40 15 55
    Race
    Units: Subjects
        Caucasian
    52 18 70
        Black
    1 0 1
    WHO performance status
    Units: Subjects
        Score of 0
    38 10 48
        Score of 1
    13 7 20
        Score of 2
    2 1 3
    Time from initial diagnosis to randomisation
    Units: Subjects
        <6 months
    10 3 13
        6 - <12 months
    3 3 6
        12 - <24 months
    11 3 14
        24 - <36 months
    7 1 8
        ≥36 months
    22 8 30
    Histology type
    Units: Subjects
        Adenocarcinoma
    3 2 5
        Clear cell carcinoma
    48 15 63
        Other
    2 1 3
    Number of metastatic sites
    Units: Subjects
        0 sites
    2 1 3
        1 site
    7 3 10
        2 sites
    19 7 26
        3 sites
    17 5 22
        4 sites
    6 2 8
        5 sites
    2 0 2
    Memorial Sloane-Kettering Cancer Center risk group
    Units: Subjects
        Favourable risk
    26 6 32
        Intermediate risk
    26 10 36
        Poor risk
    1 2 3
    Tumour size at baseline
    Units: cm
        geometric mean (standard deviation)
    11.23 ± 73.7 12.59 ± 117.7 -

    End points

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    End points reporting groups
    Reporting group title
    Cediranib 45mg
    Reporting group description
    Cediranib 45mg was be administered as a 30mg tablet and a 15mg tablet combination, taken orally once daily

    Reporting group title
    Placebo
    Reporting group description
    Cediranib placebo was be administered as a 30mg tablet and a 15mg tablet combination taken orally once daily.

    Primary: Change from baseline in tumour size at 12 weeks

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    End point title
    Change from baseline in tumour size at 12 weeks
    End point description
    End point type
    Primary
    End point timeframe
    Change from baseline in tumour size was assessed after 12 weeks of therapy (or upon progression if this occurred before 12 weeks).
    End point values
    Cediranib 45mg Placebo
    Number of subjects analysed
    51
    17
    Units: % change in tumour size
        least squares mean (inter-quartile range (Q1-Q3))
    -20.48 (-27.2 to -13.2)
    19.52 (7.7 to 32.6)
    Statistical analysis title
    Change from baseline in tumour size at Week 12
    Statistical analysis description
    The change in tumour size at week 12 (or progression if prior to week 12) was assessed as a percentage change from baseline tumour size for each patient. The effect of AZD2171 on change in tumour size was estimated from an analysis of covariance (ANCOVA) model including terms for centre, treatment (AZD2171 or placebo) and Memorial Sloan-Kettering Cancer Centre (MSKCC) risk group as well as a covariate for baseline tumour size.
    Comparison groups
    Cediranib 45mg v Placebo
    Number of subjects included in analysis
    68
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.0001
    Method
    ANCOVA
    Parameter type
    Glsmeans ratio (converted to % change)
    Point estimate
    -33.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -40
         upper limit
    -26.3
    Notes
    [1] - Glsmean = Geometric least squares mean

    Secondary: Visit response at Week 12 or at progression if before Week 12

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    End point title
    Visit response at Week 12 or at progression if before Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Same as primary
    End point values
    Cediranib 45mg Placebo
    Number of subjects analysed
    53
    18
    Units: Number of patients
        Responders
    11
    0
        Stable disease
    32
    4
        Progressive disease
    8
    13
        Non-evaluable
    2
    1
    No statistical analyses for this end point

    Secondary: Best change in tumour size during study

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    End point title
    Best change in tumour size during study
    End point description
    The best change from baseline in tumour size during the study for each patient was defined as the change in tumour size at the time when the smallest post-baseline tumour size was observed
    End point type
    Secondary
    End point timeframe
    Till final database lock
    End point values
    Cediranib 45mg Placebo
    Number of subjects analysed
    51 [2]
    17
    Units: Best change from baseline (%)
        arithmetic mean (standard deviation)
    -26.90 ± 23.15
    1.09 ± 26.78
    Notes
    [2] - Two patients known to progress but with missing target lesion data
    No statistical analyses for this end point

    Secondary: Best objective tumour response

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    End point title
    Best objective tumour response
    End point description
    The best change in tumour size is the smallest (most negative or least positive if none of the changes are negative) percentage change in tumour size from baseline. Patients who have no post-baseline target lesion size data during the study but are known to have progressed (i.e. patients with a best response of PD, patients who discontinue due to progression before their first scheduled RECIST assessment with no target lesion data entered at their discontinuation visit) had a 20% increase imputed as their best change in tumour size during the study.
    End point type
    Secondary
    End point timeframe
    Till final database lock
    End point values
    Cediranib 45mg Placebo
    Number of subjects analysed
    53
    18
    Units: Number of patients
    number (not applicable)
        Responders
    18
    1
        Stable disease
    25
    3
        Progressive disease
    9
    13
        Non-evaluable
    1
    1
    No statistical analyses for this end point

    Secondary: Duration of response

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    End point title
    Duration of response [3]
    End point description
    Response duration is measured from the time the criteria for CR/PR are first met (whichever is recorded first) until the patient progresses or dies, regardless of whether the patient is still taking study medication or starts taking another anti-cancer therapy (i.e. responses ongoing when a patient starts taking another anti-cancer therapy do not have to end in terms of duration of response if they have not progressed but responses starting on new anti-cancer therapies will not be counted in the duration of response). Non-responders are excluded from the summary of response duration.
    End point type
    Secondary
    End point timeframe
    Till final database lock
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only one patient responded in the placebo arm so it wasn’t possible to calculate a median or other statistics therefore only the AZD2171 45mg arm has been reported.
    End point values
    Cediranib 45mg
    Number of subjects analysed
    18 [4]
    Units: Months
        median (inter-quartile range (Q1-Q3))
    18.6 (12.5 to 18.6)
    Notes
    [4] - 18 responders in Cediranib arm. Not possible calculate median in Placebo arm (n=1).
    No statistical analyses for this end point

    Secondary: Progression free survival (PFS)

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    End point title
    Progression free survival (PFS)
    End point description
    This is defined as the time from randomisation to the earlier date of objective progression (measured by RECIST) or death. Objective progression is assessed for all patients using the screening assessments as the baseline measurements. Patients who were still alive at the time of data cut-off, without a progression event, are censored at the date of their last evaluable objective tumour assessment.
    End point type
    Secondary
    End point timeframe
    Till final database lock
    End point values
    Cediranib 45mg Placebo
    Number of subjects analysed
    53
    18
    Units: Events
        median (inter-quartile range (Q1-Q3))
    12.1 (5.62 to 21.4)
    2.76 (2.27 to 3.48)
    Statistical analysis title
    Cox proportional hazards model
    Comparison groups
    Cediranib 45mg v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    < 0.017
    Method
    Regression, Cox
    Parameter type
    Cox proportional hazard
    Point estimate
    0.45
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.26
         upper limit
    0.78
    Notes
    [5] - HR <1 favours cediranib

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    PLACEBO
    Reporting group description
    PLACEBO

    Reporting group title
    AZD2171 45 mg
    Reporting group description
    AZD2171 45 mg

    Serious adverse events
    PLACEBO AZD2171 45 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 18 (55.56%)
    22 / 53 (41.51%)
         number of deaths (all causes)
    1
    5
         number of deaths resulting from adverse events
    0
    1
    Vascular disorders
    HYPERTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORTHOSTATIC HYPOTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    INTRACRANIAL TUMOUR HAEMORRHAGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    FATIGUE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    AGITATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONFUSIONAL STATE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BARTHOLIN'S CYST
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    CLAVICLE FRACTURE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER LIMB FRACTURE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    BLOOD CALCIUM INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    MYOCARDIAL INFARCTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FIBRILLATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURITIC PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    APHASIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL INFARCTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEADACHE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    LOSS OF CONSCIOUSNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    REVERSIBLE POSTERIOR LEUKOENCEPHALOPATHY SYNDROME
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC ULCER HAEMORRHAGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    HEPATIC FUNCTION ABNORMAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JAUNDICE CHOLESTATIC
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    HAEMATURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHROTIC SYNDROME
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROTEINURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE ACUTE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    DERMATITIS BULLOUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN ULCER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BURSITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULAR WEAKNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULOSKELETAL CHEST PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    DEHYDRATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERCALCAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    LOWER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PLACEBO AZD2171 45 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 18 (88.89%)
    53 / 53 (100.00%)
    Vascular disorders
    FLUSHING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    HOT FLUSH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    HYPOTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    HYPERTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 18 (55.56%)
    37 / 53 (69.81%)
         occurrences all number
    10
    40
    LYMPHOEDEMA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    PERIPHERAL COLDNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    PHLEBITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    ASTHENIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    CHILLS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    FEELING COLD
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    6 / 53 (11.32%)
         occurrences all number
    0
    6
    FATIGUE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    12 / 18 (66.67%)
    37 / 53 (69.81%)
         occurrences all number
    24
    77
    GAIT DISTURBANCE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    INFLUENZA LIKE ILLNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    INJECTION SITE INDURATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    LOCAL SWELLING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    IRRITABILITY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    MUCOSAL INFLAMMATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    OEDEMA PERIPHERAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    11 / 53 (20.75%)
         occurrences all number
    2
    14
    PYREXIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 53 (7.55%)
         occurrences all number
    1
    4
    Psychiatric disorders
    ANXIETY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    CONFUSIONAL STATE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    APATHY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    DEPRESSED MOOD
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    DEPRESSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    2 / 53 (3.77%)
         occurrences all number
    5
    2
    EMOTIONAL DISORDER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    LOSS OF LIBIDO
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    INSOMNIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    7 / 53 (13.21%)
         occurrences all number
    2
    9
    PERSONALITY CHANGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    MOOD ALTERED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    3
    Reproductive system and breast disorders
    TESTICULAR CYST
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    ARTHROPOD BITE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    POST PROCEDURAL COMPLICATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    PROCEDURAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    SUNBURN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Investigations
    BLOOD POTASSIUM INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    WEIGHT DECREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 18 (27.78%)
    22 / 53 (41.51%)
         occurrences all number
    5
    26
    Cardiac disorders
    SPLINTER HAEMORRHAGES
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    9 / 53 (16.98%)
         occurrences all number
    5
    15
    DYSPHONIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 18 (50.00%)
    33 / 53 (62.26%)
         occurrences all number
    14
    47
    DYSPNOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 18 (38.89%)
    11 / 53 (20.75%)
         occurrences all number
    8
    19
    EPISTAXIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    9 / 53 (16.98%)
         occurrences all number
    1
    10
    DYSPNOEA EXERTIONAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    OROPHARYNGEAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 53 (7.55%)
         occurrences all number
    2
    5
    HAEMOPTYSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    6 / 53 (11.32%)
         occurrences all number
    0
    6
    PRODUCTIVE COUGH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 53 (7.55%)
         occurrences all number
    1
    5
    RALES
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    4 / 53 (7.55%)
         occurrences all number
    4
    4
    RHINITIS ALLERGIC
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    RHINORRHOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    5 / 53 (9.43%)
         occurrences all number
    0
    5
    Nervous system disorders
    AGEUSIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    DIZZINESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    9 / 53 (16.98%)
         occurrences all number
    5
    13
    BALANCE DISORDER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    DYSGEUSIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    9 / 53 (16.98%)
         occurrences all number
    2
    12
    HEADACHE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 18 (33.33%)
    30 / 53 (56.60%)
         occurrences all number
    10
    46
    DYSKINESIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    HYPOAESTHESIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    3
    NEUROPATHY PERIPHERAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    LETHARGY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    9 / 53 (16.98%)
         occurrences all number
    2
    11
    PARAESTHESIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 53 (9.43%)
         occurrences all number
    2
    5
    SCIATICA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    SOMNOLENCE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    BLINDNESS TRANSIENT
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    CONJUNCTIVITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    VISION BLURRED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    3
    OCULAR HYPERAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    HYPOACUSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    TINNITUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 18 (27.78%)
    14 / 53 (26.42%)
         occurrences all number
    6
    18
    ABDOMINAL PAIN UPPER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    9 / 53 (16.98%)
         occurrences all number
    0
    10
    ANAL INFLAMMATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    5
    CONSTIPATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 18 (44.44%)
    22 / 53 (41.51%)
         occurrences all number
    12
    32
    DIARRHOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 18 (83.33%)
    46 / 53 (86.79%)
         occurrences all number
    30
    124
    DRY MOUTH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    7 / 53 (13.21%)
         occurrences all number
    1
    7
    DYSPEPSIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    9 / 53 (16.98%)
         occurrences all number
    5
    13
    FLATULENCE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    GASTROOESOPHAGEAL REFLUX DISEASE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    GLOSSODYNIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    4
    GINGIVAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    2 / 53 (3.77%)
         occurrences all number
    2
    2
    HAEMORRHOIDS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    LIP SWELLING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    MOUTH ULCERATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    NAUSEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 18 (44.44%)
    31 / 53 (58.49%)
         occurrences all number
    12
    61
    ORAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    4 / 53 (7.55%)
         occurrences all number
    4
    5
    RECTAL HAEMORRHAGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    3
    STOMATITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 18 (38.89%)
    18 / 53 (33.96%)
         occurrences all number
    17
    39
    TOOTHACHE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 53 (7.55%)
         occurrences all number
    1
    4
    VOMITING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 18 (27.78%)
    16 / 53 (30.19%)
         occurrences all number
    7
    31
    Hepatobiliary disorders
    JAUNDICE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    LIVER DISORDER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    DYSURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    HAEMATURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    PROTEINURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 53 (9.43%)
         occurrences all number
    1
    6
    RENAL FAILURE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    ACTINIC KERATOSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    BLISTER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    ALOPECIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    8 / 53 (15.09%)
         occurrences all number
    3
    8
    COLD SWEAT
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    DECUBITUS ULCER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    DRY SKIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 53 (11.32%)
         occurrences all number
    1
    6
    ERYTHEMA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 53 (9.43%)
         occurrences all number
    1
    6
    HYPERKERATOSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    NIGHT SWEATS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    4
    2
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    18 / 53 (33.96%)
         occurrences all number
    9
    28
    PRURITUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    PSORIASIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    RASH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 18 (27.78%)
    13 / 53 (24.53%)
         occurrences all number
    6
    20
    RASH ERYTHEMATOUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    RASH GENERALISED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    1
    2
    RASH MACULAR
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    3 / 53 (5.66%)
         occurrences all number
    3
    5
    SCAR
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    SKIN EXFOLIATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    4
    SKIN INDURATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    SKIN ULCER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    4
    XERODERMA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    8 / 53 (15.09%)
         occurrences all number
    4
    9
    BACK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 18 (33.33%)
    16 / 53 (30.19%)
         occurrences all number
    10
    20
    ARTHROPATHY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    BONE PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    3 / 53 (5.66%)
         occurrences all number
    2
    3
    FLANK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    2 / 53 (3.77%)
         occurrences all number
    4
    2
    GROIN PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    JOINT STIFFNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    5
    JOINT SWELLING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    0
    4
    MUSCLE RIGIDITY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    MUSCULAR WEAKNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 53 (9.43%)
         occurrences all number
    1
    8
    MUSCLE SPASMS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    7 / 53 (13.21%)
         occurrences all number
    2
    9
    MUSCULOSKELETAL CHEST PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 53 (9.43%)
         occurrences all number
    1
    6
    MUSCULOSKELETAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    9 / 53 (16.98%)
         occurrences all number
    2
    12
    MUSCULOSKELETAL STIFFNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    6 / 53 (11.32%)
         occurrences all number
    0
    6
    MYALGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    7 / 53 (13.21%)
         occurrences all number
    3
    9
    MYOPATHY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    PAIN IN EXTREMITY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    10 / 53 (18.87%)
         occurrences all number
    2
    13
    NECK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    5 / 53 (9.43%)
         occurrences all number
    2
    7
    Endocrine disorders
    HYPOTHYROIDISM
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    7 / 53 (13.21%)
         occurrences all number
    2
    7
    HYPERTHYROIDISM
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    APPETITE DISORDER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    DECREASED APPETITE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 18 (38.89%)
    32 / 53 (60.38%)
         occurrences all number
    13
    52
    Infections and infestations
    INFLUENZA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    4
    LOWER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 18 (16.67%)
    10 / 53 (18.87%)
         occurrences all number
    6
    12
    NASOPHARYNGITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 18 (22.22%)
    12 / 53 (22.64%)
         occurrences all number
    4
    15
    ORAL CANDIDIASIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    ORAL HERPES
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 53 (0.00%)
         occurrences all number
    3
    0
    PHARYNGITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    PNEUMONIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 18 (11.11%)
    6 / 53 (11.32%)
         occurrences all number
    2
    6
    SINUSITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    1
    3
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 18 (5.56%)
    3 / 53 (5.66%)
         occurrences all number
    2
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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