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    Clinical Trial Results:
    A Phase II, Randomised, Factorial, Double-blind Study to Investigate the Management of AZD2171 (RECENTIN™)-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients with Advanced Solid Tumours

    Summary
    EudraCT number
    		 2005-003442-33
    Trial protocol
    		 GB   DE  
    Global end of trial date
    26 Apr 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Dec 2021
    First version publication date
    13 Dec 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D8480C00038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    1 Francis Crick Avenue, Cambridge Biomedical Campus, United Kingdom, CB2 0AA
    Public contact
    Tsveta Milenkova, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Gerard Lynch, AstraZeneca, aztrial_results_posting@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
    26 Apr 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jan 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Identify a treatment strategy, consisting of a dose of AZD2171 and a hypertension management strategy (pre-defined management of emergent hypertension ± prophylaxis) that was well tolerated without significant drug withdrawal or dose reduction during the first 12 weeks of therapy with AZD2171.
    Protection of trial subjects
    de-escalation dose recommended: CTCAE grade 3 or higher toxicities of duration >3 days that were considered to be related to study treatment and were not responding to maximal supportive care within 48 hours, at the discretion of the investigator. Excluding hypertension, toxicity attributable to AZD2171 management plan: if symptoms did not resolve to CTCAE grade 2 or below with maximum supportive care, the next dose level of AZD2171 below that being dosed was to be instituted (30mg became 20mg, 45mg became 30mg etc). Investigators could choose to reduce the dose of AZD2171, hold dosing for up to 14 days or withdraw the patient from the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Nov 2005
    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
    Germany: 38
    Country: Number of subjects enrolled
    Netherlands: 68
    Country: Number of subjects enrolled
    United Kingdom: 27
    Worldwide total number of subjects
    133
    EEA total number of subjects
    133
    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)
    103
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients enrolled = 133; ITT analysis set = 126 AZD2171 30mg (Antihypertensive prophylaxis) = 30 AZD2171 30mg (no-Antihypertensive prophylaxis) = 32 AZD2171 45mg (Antihypertensive prophylaxis) = 30 AZD2171 45mg (no-Antihypertensive prophylaxis) = 34

    Pre-assignment
    Screening details
    		 Not randomised = 7; eligibility criteria not fulfilled = 6; screening failure = 1

    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, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    randomisation was done using software and RNG. No personnel were aware of the randomisation process untill all data was collected

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AZD2171 30 mg Anti HT
    Arm description
    		 AZD2171 30 mg AntiHT prophylaxis
    Arm type
    		 Experimental

    Investigational medicinal product name
    RECENTIN™, cediranib (Anti HT - amlodipine 2.5 mg/day or nifedipine 30 mg/day or felodipine 2.5 mg/day)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AZD2171 was administered orally, once daily as a 1 x 30 mg tablet plus 1 x 15 mg placebo tablet (ie, total AZD2171 dose of 30 mg). Patients could continue indefinitely, provided they do not meet the exclusion criteria, were free from intolerable toxicity, and were receiving some benefit (in the investigator's opinion)

    Arm title
    		 AZD2171 30 mg No Anti HT
    Arm description
    		 AZD2171 30 mg No AntiHT prophylaxis
    Arm type
    		 Experimental

    Investigational medicinal product name
    RECENTIN™, cediranib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    AZD2171 was administered orally, once daily as a 1 x 30 mg tablet plus 1 x 15 mg placebo tablet (ie, total AZD2171 dose of 30 mg). Patients could continue indefinitely, provided they do not meet the exclusion criteria, were free from intolerable toxicity, and were receiving some benefit (in the investigator's opinion)

    Arm title
    		 AZD2171 45 mg Anti HT
    Arm description
    		 AZD2171 45 mg AntiHT prophylaxis
    Arm type
    		 Experimental

    Investigational medicinal product name
    RECENTIN™, cediranib (Anti HT - amlodipine 2.5 mg/day or nifedipine 30 mg/day or felodipine 2.5 mg/day)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally once daily as 1 x 30mg tablet + 1 x 15mg tablet. Patients could continue indefinitely, provided they do not meet the exclusion criteria, were free from intolerable toxicity, and were receiving some benefit (in the investigator's opinion)

    Arm title
    		 AZD2171 45 mg No Anti HT
    Arm description
    		 AZD2171 45 mg No AntiHT prophylaxis
    Arm type
    		 Experimental

    Investigational medicinal product name
    RECENTIN™, cediranib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    administered orally once daily as 1 x 30mg tablet + 1 x 15mg tablet. Patients could continue indefinitely, provided they do not meet the exclusion criteria, were free from intolerable toxicity, and were receiving some benefit (in the investigator's opinion)

    Number of subjects in period 1 [1]
    		AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT
    Started
    30
    32
    30
    34
    Completed
    13
    21
    16
    19
    Not completed
    17
    11
    14
    15
         Consent withdrawn by subject
    -
    1
    2
    2
         Adverse event, non-fatal
    2
    3
    6
    4
         Not specified
    2
    2
    -
    3
         Cond. under inv. worsened
    9
    5
    3
    4
         Development study specific disc. crit.
    1
    -
    1
    -
         Not treated
    3
    -
    2
    2
    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: Results are provided for the 126 randomized subjects, following the definition of ITT used in the study. 133 patients were enrolled, of which 7 were not randomized [(Eligibility criteria not fulfilled = 6) (Screening failure = 1)]

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD2171 30 mg Anti HT
    Reporting group description
    		 AZD2171 30 mg AntiHT prophylaxis

    Reporting group title
    AZD2171 30 mg No Anti HT
    Reporting group description
    		 AZD2171 30 mg No AntiHT prophylaxis

    Reporting group title
    AZD2171 45 mg Anti HT
    Reporting group description
    		 AZD2171 45 mg AntiHT prophylaxis

    Reporting group title
    AZD2171 45 mg No Anti HT
    Reporting group description
    		 AZD2171 45 mg No AntiHT prophylaxis

    Reporting group values
    		 AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT Total
    Number of subjects
    		 30 32 30 34 126
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 22 26 21 28 97
        From 65-84 years
    		 8 6 9 6 29
        85 years and over
    		 0 0 0 0 0
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 58.1 ( 9.3 ) 52.7 ( 12.9 ) 56.4 ( 11.0 ) 53.5 ( 11.7 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 12 16 13 25 66
        Male
    		 18 16 17 9 60
    Race
    Units: Subjects
        Caucasian
    		 28 32 29 33 122
        Black
    		 0 0 1 0 1
        Oriental
    		 1 0 0 0 1
        Other
    		 1 0 0 1 2
    Number of prior regimens
    Units: Subjects
        Zero
    		 4 9 8 6 27
        One
    		 7 7 2 6 22
        Two
    		 7 3 7 4 21
        Three
    		 1 8 4 5 18
        Four
    		 8 3 3 4 18
        Five
    		 2 1 4 6 13
        More than six
    		 1 1 2 3 7

    End points

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    End points reporting groups
    Reporting group title
    AZD2171 30 mg Anti HT
    Reporting group description
    		 AZD2171 30 mg AntiHT prophylaxis

    Reporting group title
    AZD2171 30 mg No Anti HT
    Reporting group description
    		 AZD2171 30 mg No AntiHT prophylaxis

    Reporting group title
    AZD2171 45 mg Anti HT
    Reporting group description
    		 AZD2171 45 mg AntiHT prophylaxis

    Reporting group title
    AZD2171 45 mg No Anti HT
    Reporting group description
    		 AZD2171 45 mg No AntiHT prophylaxis

    Primary: Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 12 weeks of first dose of AZD2171

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    End point title
    		 Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 12 weeks of first dose of AZD2171 [1]
    End point description
    End point type
    Primary
    End point timeframe
    12 week treatment period
    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: No formal statistical analyses were specified or conducted for this endpoint, there observed number of patients was summarised separately by treatment arm.
    End point values
    		 AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT
    Number of subjects analysed
    30
    32
    30
    34
    Units: Participants
    12
    19
    20
    24
    No statistical analyses for this end point

    Primary: Proportion of planned dose received during first 12 weeks of therapy with AZD2171

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    End point title
    		 Proportion of planned dose received during first 12 weeks of therapy with AZD2171 [2]
    End point description
    Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)
    End point type
    Primary
    End point timeframe
    12 week treatment period
    Notes
    [2] - 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: No formal statistical analyses were specified or conducted for this endpoint, there observed number of patients was summarised separately by treatment arm.
    End point values
    		 AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT
    Number of subjects analysed
    30
    32
    30
    34
    Units: Poportion of Planned Dose
        median (confidence interval 90%)
    0.89 (0.62 to 1.00)
    0.88 (0.76 to 0.98)
    0.74 (0.58 to .91)
    0.79 (0.64 to 0.87)
    No statistical analyses for this end point

    Secondary: Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 6 weeks of first dose of AZD2171

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    End point title
    		 Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 6 weeks of first dose of AZD2171
    End point description
    End point type
    Secondary
    End point timeframe
    First 6 weeks of 12 week treatment period
    End point values
    		 AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT
    Number of subjects analysed
    30
    32
    30
    34
    Units: Participants
    9
    9
    16
    19
    No statistical analyses for this end point

    Secondary: Objective response rate

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    End point title
    		 Objective response rate
    End point description
    Number of patients with complete or partial response (CR/PR), based on RECIST
    End point type
    Secondary
    End point timeframe
    12 week treatment period
    End point values
    		 AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT
    Number of subjects analysed
    29
    32
    30
    34
    Units: Participants
    1
    3
    2
    3
    No statistical analyses for this end point

    Secondary: Best percentage change in tumour size

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    End point title
    		 Best percentage change in tumour size
    End point description
    Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.
    End point type
    Secondary
    End point timeframe
    Randomisation until end of treatment period
    End point values
    		 AZD2171 30 mg Anti HT AZD2171 30 mg No Anti HT AZD2171 45 mg Anti HT AZD2171 45 mg No Anti HT
    Number of subjects analysed
    25
    29
    21
    27
    Units: percentage of tumor size
        geometric mean (confidence interval 90%)
    -1.12 (-8.96 to 7.38)
    -10.81 (-23.99 to 4.65)
    -11.78 (-22.53 to 0.46)
    -13.13 (-20.39 to -5.21)
    No statistical analyses for this end point

    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
    AZD2171 30mg AntiHT Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    AZD2171 30mg No AntiHT Prophylaxis
    Reporting group description
    		 AZD2171 30mg No AntiHT Prophylaxis

    Reporting group title
    AZD2171 45mg AntiHT Prophylaxis
    Reporting group description
    		 -

    Reporting group title
    AZD2171 45mg No AntiHT Prophylaxis
    Reporting group description
    		 AZD2171 45mg No AntiHT Prophylaxis

    Serious adverse events
    		 AZD2171 30mg AntiHT Prophylaxis AZD2171 30mg No AntiHT Prophylaxis AZD2171 45mg AntiHT Prophylaxis AZD2171 45mg No AntiHT Prophylaxis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 28 (39.29%)
    20 / 31 (64.52%)
    14 / 26 (53.85%)
    24 / 34 (70.59%)
         number of deaths (all causes)
    10
    10
    10
    14
         number of deaths resulting from adverse events
    0
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CANCER PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    HYPERTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 31 (9.68%)
    0 / 26 (0.00%)
    5 / 34 (14.71%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VENOUS THROMBOSIS LIMB
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    EUTHANASIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    FATIGUE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MALAISE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYREXIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPOXIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PLEURAL EFFUSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PNEUMOTHORAX
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    STRIDOR
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    CONFUSIONAL STATE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    BLOOD BILIRUBIN INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    MYOCARDIAL ISCHAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PALPITATIONS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SINUS TACHYCARDIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBRAL ISCHAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HAEMORRHAGE INTRACRANIAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    HEMIPARESIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SOMNOLENCE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    RETINAL VEIN THROMBOSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL PAIN LOWER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASCITES
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CONSTIPATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 31 (9.68%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DYSPHAGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ILEUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LARGE INTESTINAL HAEMORRHAGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    NAUSEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PANCREATITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SUBILEUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VOMITING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    3 / 34 (8.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    2 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHOLESTASIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    LEUKOPLAKIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    HAEMATURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PROTEINURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RENAL IMPAIRMENT
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    URETHRAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    BACK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    JOINT SWELLING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    MYALGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ERYSIPELAS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INFECTED SKIN ULCER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LARYNGITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LUNG INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    PYELONEPHRITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UROSEPSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    ANOREXIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    3 / 26 (11.54%)
    2 / 34 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    DEHYDRATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERCALCAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPONATRAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AZD2171 30mg AntiHT Prophylaxis AZD2171 30mg No AntiHT Prophylaxis AZD2171 45mg AntiHT Prophylaxis AZD2171 45mg No AntiHT Prophylaxis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 28 (96.43%)
    31 / 31 (100.00%)
    26 / 26 (100.00%)
    34 / 34 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    CANCER PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 31 (6.45%)
    2 / 26 (7.69%)
    5 / 34 (14.71%)
         occurrences all number
    6
    2
    2
    6
    Vascular disorders
    FLUSHING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    0
    2
    HYPERTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 28 (53.57%)
    21 / 31 (67.74%)
    19 / 26 (73.08%)
    25 / 34 (73.53%)
         occurrences all number
    16
    26
    23
    30
    HYPOTENSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    1
    1
    General disorders and administration site conditions
    ASTHENIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    1
    1
    1
    2
    CHEST DISCOMFORT
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    CHILLS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences all number
    4
    1
    1
    1
    FACE OEDEMA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    FATIGUE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    19 / 28 (67.86%)
    20 / 31 (64.52%)
    20 / 26 (76.92%)
    23 / 34 (67.65%)
         occurrences all number
    23
    28
    25
    29
    INFLUENZA LIKE ILLNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    4
    1
    0
    4
    MUCOSAL INFLAMMATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    4 / 31 (12.90%)
    3 / 26 (11.54%)
    3 / 34 (8.82%)
         occurrences all number
    1
    4
    4
    4
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    3 / 34 (8.82%)
         occurrences all number
    0
    1
    3
    3
    OEDEMA PERIPHERAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 31 (9.68%)
    2 / 26 (7.69%)
    3 / 34 (8.82%)
         occurrences all number
    2
    5
    2
    3
    PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    0
    2
    PYREXIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    5 / 31 (16.13%)
    2 / 26 (7.69%)
    3 / 34 (8.82%)
         occurrences all number
    3
    6
    3
    3
    TEMPERATURE INTOLERANCE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    1
    1
    Respiratory, thoracic and mediastinal disorders
    COUGH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 28 (14.29%)
    7 / 31 (22.58%)
    6 / 26 (23.08%)
    9 / 34 (26.47%)
         occurrences all number
    5
    9
    8
    13
    DYSPHONIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 28 (53.57%)
    16 / 31 (51.61%)
    19 / 26 (73.08%)
    18 / 34 (52.94%)
         occurrences all number
    16
    17
    24
    23
    DYSPNOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    5 / 31 (16.13%)
    3 / 26 (11.54%)
    6 / 34 (17.65%)
         occurrences all number
    4
    5
    6
    7
    DYSPNOEA EXERTIONAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 31 (9.68%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    3
    0
    0
    EPISTAXIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 31 (9.68%)
    2 / 26 (7.69%)
    2 / 34 (5.88%)
         occurrences all number
    0
    3
    2
    2
    NASAL CONGESTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    2 / 26 (7.69%)
    1 / 34 (2.94%)
         occurrences all number
    0
    0
    2
    1
    PHARYNGOLARYNGEAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    3 / 34 (8.82%)
         occurrences all number
    0
    1
    1
    3
    PLEURAL EFFUSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    1
    2
    Psychiatric disorders
    CONFUSIONAL STATE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    1
    2
    DEPRESSION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    3 / 31 (9.68%)
    0 / 26 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    0
    3
    0
    4
    INSOMNIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    5 / 31 (16.13%)
    2 / 26 (7.69%)
    0 / 34 (0.00%)
         occurrences all number
    1
    6
    3
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    5 / 34 (14.71%)
         occurrences all number
    2
    2
    0
    5
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    2
    1
    0
    3
    BLOOD ALBUMIN DECREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    BLOOD ALKALINE PHOSPHATASE INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    0
    0
    3
    BLOOD BILIRUBIN INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    1
    BLOOD CREATININE INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    BLOOD THYROID STIMULATING HORMONE INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 31 (6.45%)
    2 / 26 (7.69%)
    5 / 34 (14.71%)
         occurrences all number
    5
    2
    3
    8
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    4 / 34 (11.76%)
         occurrences all number
    1
    0
    0
    4
    TRANSAMINASES INCREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    2
    1
    2
    2
    WEIGHT DECREASED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 28 (17.86%)
    8 / 31 (25.81%)
    8 / 26 (30.77%)
    5 / 34 (14.71%)
         occurrences all number
    5
    10
    8
    5
    Cardiac disorders
    SINUS BRADYCARDIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    SINUS TACHYCARDIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Nervous system disorders
    DIZZINESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    3 / 31 (9.68%)
    6 / 26 (23.08%)
    6 / 34 (17.65%)
         occurrences all number
    2
    4
    8
    7
    DYSGEUSIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    0
    1
    HEADACHE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    7 / 31 (22.58%)
    9 / 26 (34.62%)
    7 / 34 (20.59%)
         occurrences all number
    3
    10
    10
    8
    MEMORY IMPAIRMENT
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    0
    2
    NEURALGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    NEUROPATHY PERIPHERAL
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences all number
    2
    0
    1
    0
    PERIPHERAL SENSORY NEUROPATHY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 31 (9.68%)
    1 / 26 (3.85%)
    3 / 34 (8.82%)
         occurrences all number
    4
    4
    1
    3
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    5 / 31 (16.13%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    6
    0
    2
    NEUTROPENIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    THROMBOCYTOPENIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    5 / 34 (14.71%)
         occurrences all number
    0
    1
    1
    8
    Ear and labyrinth disorders
    EAR DISCOMFORT
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences all number
    2
    2
    1
    1
    TINNITUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    1
    2
    Eye disorders
    VISION BLURRED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 31 (9.68%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    1
    3
    0
    0
    VISUAL ACUITY REDUCED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    3 / 26 (11.54%)
    0 / 34 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 31 (9.68%)
    6 / 26 (23.08%)
    8 / 34 (23.53%)
         occurrences all number
    5
    3
    8
    8
    ABDOMINAL PAIN LOWER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    1
    0
    ABDOMINAL PAIN UPPER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    4 / 26 (15.38%)
    4 / 34 (11.76%)
         occurrences all number
    0
    2
    4
    5
    ASCITES
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    5
    1
    1
    2
    CONSTIPATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 28 (21.43%)
    9 / 31 (29.03%)
    5 / 26 (19.23%)
    9 / 34 (26.47%)
         occurrences all number
    8
    14
    6
    10
    DIARRHOEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    24 / 28 (85.71%)
    23 / 31 (74.19%)
    20 / 26 (76.92%)
    25 / 34 (73.53%)
         occurrences all number
    43
    50
    40
    51
    DRY MOUTH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 31 (9.68%)
    6 / 26 (23.08%)
    5 / 34 (14.71%)
         occurrences all number
    3
    3
    6
    5
    DYSPEPSIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 28 (14.29%)
    3 / 31 (9.68%)
    3 / 26 (11.54%)
    3 / 34 (8.82%)
         occurrences all number
    4
    3
    3
    6
    DYSPHAGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    2 / 31 (6.45%)
    4 / 26 (15.38%)
    6 / 34 (17.65%)
         occurrences all number
    3
    3
    6
    10
    FLATULENCE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    0 / 31 (0.00%)
    2 / 26 (7.69%)
    4 / 34 (11.76%)
         occurrences all number
    3
    0
    2
    4
    HAEMORRHOIDS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    2
    1
    MOUTH ULCERATION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    1
    2
    NAUSEA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 28 (32.14%)
    17 / 31 (54.84%)
    8 / 26 (30.77%)
    18 / 34 (52.94%)
         occurrences all number
    13
    21
    8
    31
    RECTAL HAEMORRHAGE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    STOMATITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 28 (25.00%)
    10 / 31 (32.26%)
    13 / 26 (50.00%)
    13 / 34 (38.24%)
         occurrences all number
    9
    12
    23
    19
    VOMITING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 28 (28.57%)
    9 / 31 (29.03%)
    5 / 26 (19.23%)
    10 / 34 (29.41%)
         occurrences all number
    12
    15
    8
    16
    Skin and subcutaneous tissue disorders
    ALOPECIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    5 / 26 (19.23%)
    4 / 34 (11.76%)
         occurrences all number
    0
    0
    5
    4
    DRY SKIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 28 (17.86%)
    5 / 31 (16.13%)
    6 / 26 (23.08%)
    7 / 34 (20.59%)
         occurrences all number
    6
    6
    6
    8
    ERYTHEMA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    2
    1
    HYPERHIDROSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    2 / 26 (7.69%)
    2 / 34 (5.88%)
         occurrences all number
    0
    2
    2
    3
    HYPERKERATOSIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    2
    0
    0
    2
    NAIL DISORDER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 31 (9.68%)
    3 / 26 (11.54%)
    3 / 34 (8.82%)
         occurrences all number
    2
    4
    4
    3
    PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 28 (17.86%)
    5 / 31 (16.13%)
    10 / 26 (38.46%)
    10 / 34 (29.41%)
         occurrences all number
    5
    7
    15
    14
    PIGMENTATION DISORDER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    1 / 34 (2.94%)
         occurrences all number
    0
    1
    2
    1
    PRURITUS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 31 (3.23%)
    4 / 26 (15.38%)
    2 / 34 (5.88%)
         occurrences all number
    3
    1
    4
    3
    RASH
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    6 / 26 (23.08%)
    3 / 34 (8.82%)
         occurrences all number
    0
    1
    7
    4
    RASH GENERALISED
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    1
    2
    Renal and urinary disorders
    DYSURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    3 / 34 (8.82%)
         occurrences all number
    1
    2
    1
    3
    POLLAKIURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    0
    2
    0
    1
    PROTEINURIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    4 / 31 (12.90%)
    2 / 26 (7.69%)
    5 / 34 (14.71%)
         occurrences all number
    0
    4
    2
    6
    Endocrine disorders
    HYPOTHYROIDISM
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 31 (12.90%)
    5 / 26 (19.23%)
    8 / 34 (23.53%)
         occurrences all number
    2
    5
    5
    9
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    6 / 31 (19.35%)
    6 / 26 (23.08%)
    5 / 34 (14.71%)
         occurrences all number
    3
    6
    7
    5
    BACK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 28 (14.29%)
    5 / 31 (16.13%)
    4 / 26 (15.38%)
    4 / 34 (11.76%)
         occurrences all number
    5
    5
    4
    4
    JOINT SWELLING
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    2 / 26 (7.69%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    2
    2
    MUSCLE SPASMS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    3 / 34 (8.82%)
         occurrences all number
    0
    1
    2
    5
    MUSCULAR WEAKNESS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 31 (3.23%)
    2 / 26 (7.69%)
    2 / 34 (5.88%)
         occurrences all number
    3
    1
    4
    3
    MUSCULOSKELETAL CHEST PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    0
    0
    0
    4
    MUSCULOSKELETAL PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    2
    0
    0
    2
    MYALGIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 28 (17.86%)
    2 / 31 (6.45%)
    6 / 26 (23.08%)
    5 / 34 (14.71%)
         occurrences all number
    6
    2
    10
    6
    NECK PAIN
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    1 / 26 (3.85%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    1
    0
    PAIN IN EXTREMITY
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    5 / 31 (16.13%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    2
    6
    0
    4
    Infections and infestations
    CYSTITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 31 (3.23%)
    1 / 26 (3.85%)
    3 / 34 (8.82%)
         occurrences all number
    1
    1
    1
    3
    GASTROINTESTINAL INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    2 / 26 (7.69%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    2
    0
    HERPES ZOSTER
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    0 / 34 (0.00%)
         occurrences all number
    0
    2
    0
    0
    LOWER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    0
    2
    NASOPHARYNGITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 28 (10.71%)
    7 / 31 (22.58%)
    4 / 26 (15.38%)
    1 / 34 (2.94%)
         occurrences all number
    4
    9
    5
    1
    ORAL CANDIDIASIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    2
    1
    0
    1
    RASH PUSTULAR
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    2 / 26 (7.69%)
    0 / 34 (0.00%)
         occurrences all number
    0
    0
    2
    0
    RHINITIS
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 31 (6.45%)
    0 / 26 (0.00%)
    1 / 34 (2.94%)
         occurrences all number
    1
    2
    0
    1
    UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    5 / 26 (19.23%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    6
    2
    URINARY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    3 / 31 (9.68%)
    3 / 26 (11.54%)
    3 / 34 (8.82%)
         occurrences all number
    1
    3
    3
    3
    VIRAL INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    0
    1
    0
    2
    VIRAL UPPER RESPIRATORY TRACT INFECTION
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 31 (0.00%)
    0 / 26 (0.00%)
    2 / 34 (5.88%)
         occurrences all number
    1
    0
    0
    2
    Metabolism and nutrition disorders
    ANOREXIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 28 (28.57%)
    14 / 31 (45.16%)
    13 / 26 (50.00%)
    13 / 34 (38.24%)
         occurrences all number
    10
    18
    18
    20
    DECREASED APPETITE
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 31 (3.23%)
    0 / 26 (0.00%)
    3 / 34 (8.82%)
         occurrences all number
    1
    2
    0
    3
    HYPERCALCAEMIA
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 31 (0.00%)
    1 / 26 (3.85%)
    2 / 34 (5.88%)
         occurrences all number
    0
    0
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Sep 2005
    Radiological tumour assessment at visit 15 was made optional for patients with progressive disease, or unconfirmed partial or complete response at visit 11. For all other patients the visit 15 radiological assessment was removed.
    27 Sep 2005
    Synopsis, secondary objective #1 and efficacy variables; Section 4.2, secondary objective #1; Study Plan in Table 2; Section 5.5.3.2, objective tumour response rate
    27 Sep 2005
    The recording of chemotherapy following discontinuation was removed.
    27 Sep 2005
    Haematocrit was added to the panel of haematology assessments.
    04 Dec 2006
    The first secondary objective was split into 2 separate objectives.
    04 Dec 2006
    An additional exploratory objective was added to investigate the relationship between hypertension and the effects of AZD2171 on angiogenesis biomarkers and clinical efficacy
    04 Dec 2006
    The target patient population text was amended to include the wording ‘with the exception of prostate cancer’
    04 Dec 2006
    The grouping of the primary outcome variables under the heading ‘efficacy’ was corrected
    04 Dec 2006
    Time-point information was added to the blood pressure safety variables
    04 Dec 2006
    The wording detailing when the radiological and clinical tumour assessments were performed was changed from ‘within 3 weeks of the first dose of AZD2171’ to ‘within 3 weeks prior to randomisation’. The wording detailing when pregnancy tests were to be performed was changed from ‘within 3 days prior to randomisation’ to within 3 days prior to first study drug administration’
    04 Dec 2006
    The text detailing the method of assessment of blood pressure changes was amended to include the wording ‘and when clinically indicated’.
    04 Dec 2006
    The wording detailing the timings for the assessment of ambulatory blood pressure was amended.
    04 Dec 2006
    The following sentence: ‘The 95% CIs for both variables have also been produced and will be used as a sensitivity analysis’ was added to the text detailing the analysis of the primary variables.

    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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