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    Clinical Trial Results:
    A phase II study exploring the safety and efficacy of nintedanib (BIBF1120) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.

    Summary
    EudraCT number
    		 2012-004295-19
    Trial protocol
    		 BE   IT   GB   NL   DK   FR   ES   PL  
    Global end of trial date
    28 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2020
    First version publication date
    01 May 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01788982
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    European Organisation for the Research and Treatment of Cancer
    Sponsor organisation address
    Avenue E. Mounier 83/11 , Brussels, Belgium, 1200
    Public contact
    Regulatory Affairs Department, European Organisation for the Research and Treatment of Cancer, +32 2 774 1023, regulatory@eortc.be
    Scientific contact
    Regulatory Affairs Department, European Organisation for the Research and Treatment of Cancer, +32 2 774 1023, regulatory@eortc.be
    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
    28 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Aug 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to explore the efficacy of nintedanib (as measured by progression free survival) as second line therapy for patients with either differentiated or medullary thyroid cancer progressing after first line therapy.
    Protection of trial subjects
    Protection of trial subjects: The responsible investigator ensured that this study was conducted in agreement with either the Declaration of Helsinki (available on the World Medical Association web site (http://www.wma.net)) and/or the laws and regulations of the country, whichever provides the greatest protection of the patient. The protocol had been written, and the study was conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice (ICH-GCP, available online at http://www.ema.europa.eu/pdfs/human/ich/013595en.pdf). The protocol was approved by the competent ethics committee(s) as required by the applicable national legislation.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2014
    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
    Netherlands: 10
    Country: Number of subjects enrolled
    Poland: 6
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Denmark: 5
    Country: Number of subjects enrolled
    France: 34
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 12
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    57
    From 65 to 84 years
    45
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was screened on 18 June, 2014. On 21 February, 2018, when accrual to the study was closed for poor accrual, 102 patients were registered in the study by 22 sites in 9 countries. Of the 102 patients who were screened and registered, 101 (99%) were randomized.

    Pre-assignment
    Screening details
    		 Histologically confirmed differentiated or medullary thyroid cancer by local pathologist; Locally advanced or metastatic disease deemed incurable by surgery, radiotherapy, RAI; must have received at least one but no more than two line(s) of treatment; Age ≥18 years; WHO performance status 0-1; Life expectancy > 12 weeks.

    Period 1
    Period 1 title
    Blinded period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTC - Placebo
    Arm description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: Capsules matching 400 mg of Nintedanib (200 mg twice daily), contains 0 mg of Nintedanib. Administration details: Two capsules of 100mg should be swallowed in the morning and two capsules of 100mg should be swallowed in the evening unchewed with a glass of water of about 250 ml. The dose interval should be around 12 hours at the same time every day, usually in the morning and the evening after food intake. Continues until progression of disease or until criteria for interruption of treatment are met.

    Arm title
    		 DTC - Nintedanib
    Arm description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Nintedanib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nintedanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 400 mg (200 mg twice daily). Administration details: Two capsules each containing 100mg nintedanib should be swallowed in the morning and two capsules each containing 100mg nintedanib should be swallowed in the evening unchewed with a glass of water of about 250 ml. The dose interval should be around 12 hours at the same time every day, usually in the morning and the evening after food intake. Daily dosing continues until progression of disease or until criteria for interruption of treatment are met.

    Arm title
    		 MTC - Placebo
    Arm description
    		 Patients diagnosed as Medullary Thyroid Cancer (MTC) who were randomized to receive Placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: Capsules matching 400 mg of Nintedanib (200 mg twice daily), contains 0 mg of Nintedanib. Administration details: Two capsules of 100mg should be swallowed in the morning and two capsules of 100mg should be swallowed in the evening unchewed with a glass of water of about 250 ml. The dose interval should be around 12 hours at the same time every day, usually in the morning and the evening after food intake. Continues until progression of disease or until criteria for interruption of treatment are met.

    Arm title
    		 MTC - Nintedanib
    Arm description
    		 Patients diagnosed as Medullary Thyroid Cancer (MTC) who were randomized to receive Nintedanib.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nintedanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 400 mg (200 mg twice daily). Administration details: Two capsules each containing 100mg nintedanib should be swallowed in the morning and two capsules each containing 100mg nintedanib should be swallowed in the evening unchewed with a glass of water of about 250 ml. The dose interval should be around 12 hours at the same time every day, usually in the morning and the evening after food intake. Daily dosing continues until progression of disease or until criteria for interruption of treatment are met.

    Number of subjects in period 1 [1]
    		DTC - Placebo DTC - Nintedanib MTC - Placebo MTC - Nintedanib
    Started
    25
    45
    9
    22
    Completed
    25
    44
    9
    22
    Not completed
    0
    1
    0
    0
         Early death prior to planned start of treatment
    -
    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: Only patients that were randomized are reported in the baseline period. As one patient was enrolled but not randomized due to fast general deterioration, only 101/102 patients were reported for the baseline period.
    Period 2
    Period 2 title
    Open-label period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Cross-over
    Arm description
    		 Patients in placebo arm who chose to cross over to receive Nintedanib upon progression.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nintedanib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dosage: 400 mg (200 mg twice daily). Administration details: Two capsules each containing 100mg nintedanib should be swallowed in the morning and two capsules each containing 100mg nintedanib should be swallowed in the evening unchewed with a glass of water of about 250 ml. The dose interval should be around 12 hours at the same time every day, usually in the morning and the evening after food intake. Daily dosing continues until progression of disease or until criteria for interruption of treatment are met.

    Number of subjects in period 2 [2]
    		Cross-over
    Started
    22
    Completed
    21
    Not completed
    1
         Lost to follow-up
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: The second period only consists of patients from the blinded period that progressed under placebo and chose to cross-over to the experimental treatment (Nintedanib). As such it only corresponds to a small number of patients from the preceding period, not all of them.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    DTC - Placebo
    Reporting group description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Placebo.

    Reporting group title
    DTC - Nintedanib
    Reporting group description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Nintedanib.

    Reporting group title
    MTC - Placebo
    Reporting group description
    		 Patients diagnosed as Medullary Thyroid Cancer (MTC) who were randomized to receive Placebo.

    Reporting group title
    MTC - Nintedanib
    Reporting group description
    		 Patients diagnosed as Medullary Thyroid Cancer (MTC) who were randomized to receive Nintedanib.

    Reporting group values
    		 DTC - Placebo DTC - Nintedanib MTC - Placebo MTC - Nintedanib Total
    Number of subjects
    		 25 45 9 22 101
    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)
    		 13 20 7 16 56
        From 65-84 years
    		 12 25 2 6 45
        85 years and over
    		 0 0 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 14 25 2 6 47
        Male
    		 11 20 7 16 54

    End points

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    End points reporting groups
    Reporting group title
    DTC - Placebo
    Reporting group description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Placebo.

    Reporting group title
    DTC - Nintedanib
    Reporting group description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Nintedanib.

    Reporting group title
    MTC - Placebo
    Reporting group description
    		 Patients diagnosed as Medullary Thyroid Cancer (MTC) who were randomized to receive Placebo.

    Reporting group title
    MTC - Nintedanib
    Reporting group description
    		 Patients diagnosed as Medullary Thyroid Cancer (MTC) who were randomized to receive Nintedanib.
    Reporting group title
    Cross-over
    Reporting group description
    		 Patients in placebo arm who chose to cross over to receive Nintedanib upon progression.

    Primary: Progression-Free Survival (PFS)

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    End point title
    		 Progression-Free Survival (PFS)
    End point description
    All survival estimates and statistical analyses reported for that endpoint are done on the Per Protocol (PP) population: all eligible patients that started their randomized treatment.
    End point type
    Primary
    End point timeframe
    Progression Free Survival (PFS) is defined as the time interval between the date of randomization and the date of disease progression or death, whichever comes first.
    End point values
    		 DTC - Placebo DTC - Nintedanib MTC - Placebo MTC - Nintedanib
    Number of subjects analysed
    19
    37
    5
    15
    Units: % at 5 months
        number (confidence interval 80%)
    36.8 (23.0 to 50.7)
    46.0 (35.2 to 56.0)
    40.0 (13.9 to 65.3)
    60.0 (42.0 to 74.0)
    Statistical analysis title
    		 Primary analysis - DTC
    Statistical analysis description
    The comparison for the primary endpoint was performed on the Per Protocol population. Cox regression was used to compare the experimental versus the control arms in DTC patients, stratified by country, with 1-sided 10% significant level test.
    Comparison groups
    DTC - Placebo v DTC - Nintedanib
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0947
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.65
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 0.99
    Statistical analysis title
    		 Primary analysis - MTC
    Statistical analysis description
    This analysis was done on the Per Protocol population. Since the study did not reach the targeted statistical power, no inferential test were performed for the MTC cohort. Only the unadjusted treatment effect (univariate, no stratification factors) from Cox model were reported with its 95% confidence interval, as defined in the modified Statistical Analysis Plan (SAP).
    Comparison groups
    MTC - Placebo v MTC - Nintedanib
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 1.53

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    All survival estimates and statistical analyses reported for that endpoint are done on the Per Protocol (PP) population: all eligible patients that started their randomized treatment.
    End point type
    Secondary
    End point timeframe
    Overall Survival (OS) is defined as the time interval between the date of randomization and the date of death from any cause. If no event has been observed, then the patient is censored at the last date known to be alive.
    End point values
    		 DTC - Placebo DTC - Nintedanib MTC - Placebo MTC - Nintedanib
    Number of subjects analysed
    19
    37
    5
    15
    Units: % at 5 months
        number (confidence interval 80%)
    84.2 (69.7 to 92.1)
    89.0 (80.1 to 94.0)
    999 (999 to 999)
    93.3 (78.0 to 98.1)
    Statistical analysis title
    		 Primary analysis - DTC
    Statistical analysis description
    This analysis is applied on the Per Protocol population, with the secondary endpoint of Overall Survival this time. Cox regression was used to compare the experimental versus the control arms in DTC patients, stratified by country, with 1-sided 10% significant level test.
    Comparison groups
    DTC - Placebo v DTC - Nintedanib
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4969
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 0.8%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.84
    Statistical analysis title
    		 Primary analysis - MTC
    Statistical analysis description
    This analysis was done on the Per Protocol population, for overall survival this time. Since the study did not reach the targeted statistical power, no inferential test were performed for the MTC cohort. Only the unadjusted treatment effect (univariate, no stratification factors) from Cox model were reported with its 95% confidence interval, in accordance with the modified Statistical Analysis Plan (SAP).
    Comparison groups
    MTC - Placebo v MTC - Nintedanib
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.24
         upper limit
    		 3.21

    Secondary: PFS at second progression (PFS-2)

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    End point title
    		 PFS at second progression (PFS-2)
    End point description
    The results are reported for the Per Protocol (PP) population. All eligible patients that started their randomized treatment (during the blinded period).
    End point type
    Secondary
    End point timeframe
    This endpoint is only applicable for patients in placebo arm who cross over to receive Nintedanib upon first progression. PFS-2 is calculated as the time between randomization and second progression or death, whichever comes first.
    End point values
    		 Cross-over
    Number of subjects analysed
    16
    Units: % at 5 months
        number (confidence interval 80%)
    87.5 (71.8 to 94.8)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected on a CRF to be submitted at pre-specified timepoint: -During treatment, on first day of each cycle prior treatment administration -At the end of protocol visit (4 weeks (+/- 1 week) after last treatment administration)
    Adverse event reporting additional description
    Reporting of AEs and SAE are limited to the blinded (randomized) period and is done according to NCI-CTCAE v 4.0.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCI-CTCAE
    Dictionary version
    4.0
    Reporting groups
    Reporting group title
    DTC - Placebo
    Reporting group description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Placebo.

    Reporting group title
    DTC - Nintedanib
    Reporting group description
    		 Patients diagnosed as Differentiated Thyroid Cancer (DTC) who were randomized to receive Nintedanib.

    Reporting group title
    MTC - Placebo
    Reporting group description
    		 Patients diagnosed as Medullary Thyroid Cancer (DTC) who were randomized to receive Placebo.

    Reporting group title
    MTC - Nintedanib
    Reporting group description
    		 Patients diagnosed as Medullary Thyroid Cancer (DTC) who were randomized to receive Nintedanib.

    Serious adverse events
    		 DTC - Placebo DTC - Nintedanib MTC - Placebo MTC - Nintedanib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 25 (28.00%)
    10 / 44 (22.73%)
    5 / 9 (55.56%)
    7 / 22 (31.82%)
         number of deaths (all causes)
    18
    30
    6
    15
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    NEOPLASM PROGRESSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    SUPERIOR VENA CAVA SYNDROME
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    VENA CAVA THROMBOSIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    General disorders and administration site conditions
    DEATH
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    INFLUENZA LIKE ILLNESS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    Respiratory, thoracic and mediastinal disorders
    LUNG DISORDER
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    RESPIRATORY FAILURE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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 / 1
    Psychiatric disorders
    DEPRESSED MOOD
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASPARTATE AMINOTRANSFERASE INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LIVER FUNCTION TEST ABNORMAL
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    ATRIAL FIBRILLATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CARDIAC ARREST
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    CARDIAC FAILURE ACUTE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    PERICARDIAL EFFUSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    Nervous system disorders
    CEREBRAL INFARCTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    1 / 1
    0 / 0
    CEREBROVASCULAR ACCIDENT
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    HEADACHE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    SCIATICA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    Blood and lymphatic system disorders
    ANAEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (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
    Gastrointestinal disorders
    COLONIC FISTULA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    DIARRHOEA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    DIVERTICULAR PERFORATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    PANCREATITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    VOMITING
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HEPATIC FUNCTION ABNORMAL
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    HYPERTRANSAMINASAEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    Infections and infestations
    DEVICE RELATED INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    ERYSIPELAS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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
    OPPORTUNISTIC INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (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
    PNEUMONIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (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
    RESPIRATORY TRACT INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         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 / 1
    SEPSIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    Metabolism and nutrition disorders
    DECREASED APPETITE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERCALCAEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (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
    HYPOCALCAEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 DTC - Placebo DTC - Nintedanib MTC - Placebo MTC - Nintedanib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 25 (100.00%)
    41 / 44 (93.18%)
    8 / 9 (88.89%)
    21 / 22 (95.45%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    TUMOR PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    4
    0
    0
    Vascular disorders
    FLUSHING
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    HYPERTENSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    6 / 25 (24.00%)
    13 / 44 (29.55%)
    2 / 9 (22.22%)
    6 / 22 (27.27%)
         occurrences all number
    12
    23
    5
    13
    THROMBOEMBOLIC EVENT
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    2 / 44 (4.55%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    2
    6
    1
    0
    WHITE FINGERS IN THE COLD
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    Surgical and medical procedures
    AMPUTATION TOE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    EDEMA LIMBS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    FATIGUE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    7 / 25 (28.00%)
    15 / 44 (34.09%)
    5 / 9 (55.56%)
    8 / 22 (36.36%)
         occurrences all number
    8
    26
    5
    15
    FEVER
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 44 (6.82%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    5
    0
    0
    FLU LIKE SYMPTOMS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    GAIT DISTURBANCE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    LOCALIZED EDEMA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    MALAISE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    NON-CARDIAC CHEST PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    3 / 44 (6.82%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    3
    0
    2
    THORACIC PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    ALLERGIC REACTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    ALLERGIC REACTION TO BLOOD TRANSFUSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    ALLERGIC RHINITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    BRONCHOPULMONARY HEMORRHAGE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    4
    0
    0
    COUGH
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 44 (6.82%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    8
    0
    0
    DYSPNEA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    6 / 25 (24.00%)
    8 / 44 (18.18%)
    1 / 9 (11.11%)
    2 / 22 (9.09%)
         occurrences all number
    9
    10
    1
    2
    PHARYNGEAL MUCOSITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PLEURAL EFFUSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    0
    0
    1
    PNEUMONIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PNEUMONITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    RESPIRATORY INSUFFISIENCY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Psychiatric disorders
    AGITATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    ANXIETY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    1
    0
    DEPRESSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    0
    INSOMNIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    ALKALINE PHOSPHATASE INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    0
    1
    C REACTIVE PROTEIN INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    C REACTIVE PROTEINE INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    GGT INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 44 (9.09%)
    0 / 9 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    2
    5
    0
    7
    IRON INSUFFICIENCY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    LYMPHOCYTE COUNT DECREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    SERUM AMYLASE INCREASED
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    VITAMIN B9 DEFICIENCY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    WEIGHT GAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    WEIGHT LOSS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    6 / 25 (24.00%)
    10 / 44 (22.73%)
    3 / 9 (33.33%)
    9 / 22 (40.91%)
         occurrences all number
    8
    15
    5
    13
    Injury, poisoning and procedural complications
    FOOD POISONING
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    ATRIAL FIBRILLATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    4
    1
    0
    1
    CARDIAC ARREST
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HEART FAILURE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    PALPITATIONS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    PERICARDIAL EFFUSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    Nervous system disorders
    DEPRESSED LEVEL OF CONSCIOUSNESS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    DIZZINESS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    0
    1
    DYSGEUSIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    1
    0
    FACIAL PARESIS LEFT
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HEADACHE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    5 / 44 (11.36%)
    1 / 9 (11.11%)
    2 / 22 (9.09%)
         occurrences all number
    1
    10
    1
    2
    INSIPIENT MECHANICAL CORD COMPRESSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    INTRACRANIAL HEMORRHAGE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    1
    0
    LETHARGY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    0
    0
    0
    5
    LINGUAL PARESTHESIAS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    PARAPLEGIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    PARESTHESIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    PERIPHERAL MOTOR NEUROPATHY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    RADICULITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SCIATICA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SOMNOLENCE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SPINAL CORD COMPRESSION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    STROKE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood and lymphatic system disorders
    NEUTROPHILIC LEUKOCYTOSIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye disorders
    BLURRED VISION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    LOSS OF VISION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    7 / 44 (15.91%)
    0 / 9 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    1
    10
    0
    3
    ANAL HEMORRHAGE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    COLITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    COLONIC PERFORATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    CONSTIPATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 44 (6.82%)
    0 / 9 (0.00%)
    3 / 22 (13.64%)
         occurrences all number
    0
    5
    0
    4
    DIARRHEA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    22 / 44 (50.00%)
    4 / 9 (44.44%)
    12 / 22 (54.55%)
         occurrences all number
    3
    37
    4
    26
    DRY MOUTH
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    2
    0
    1
    1
    DYSPHAGIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    ENTEROCOLITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    GASTRITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    GASTROESOPHAGEAL REFLUX DISEASE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    1
    1
    GASTROINTESTINAL PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    INTERMITANT INDEGESTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    LOSS OF APETITE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    MUCOSITIS ORAL
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    3
    0
    0
    NAUSEA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    15 / 44 (34.09%)
    1 / 9 (11.11%)
    8 / 22 (36.36%)
         occurrences all number
    2
    22
    1
    14
    ORAL PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    STOMACH PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    4 / 44 (9.09%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    7
    0
    0
    VOMITING
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    3 / 25 (12.00%)
    11 / 44 (25.00%)
    0 / 9 (0.00%)
    4 / 22 (18.18%)
         occurrences all number
    3
    16
    0
    4
    Hepatobiliary disorders
    CHOLECYSTITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Skin and subcutaneous tissue disorders
    ALOPECIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 44 (9.09%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    4
    0
    0
    BLEEDING FROM THE NECK TUMOR (SKIN INFILTRATION)
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    DRY SKIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    4 / 25 (16.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    4
    0
    1
    1
    ERYTHEMA RIGHT UPPER LEG
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    LEFT THORACIC CUTANEOUS PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    PAIN OF SKIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    PRURITUS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    0
    1
    RASH (SHAVING)
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    RASH ACNEIFORM
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    RASH MACULO-PAPULAR
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 44 (4.55%)
    1 / 9 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    1
    2
    1
    1
    SCALP DISCOLORATIONS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SKIN INDURATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    URTICARIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Renal and urinary disorders
    ACUTE KIDNEY INJURY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    HEMATURIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    RENAL COLIC
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    3
    URINARY RETENTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    HYPERTHYROIDISM
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    ARTHRITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    BACK PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    3
    1
    0
    1
    BONE PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    1 / 9 (11.11%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    1
    1
    CHEST WALL PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    CRAMPING LEFT FOOT
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    FLANK PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    LUMBOISCHIALGIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    MUSCLE PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    MYALGIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    3 / 25 (12.00%)
    3 / 44 (6.82%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    3
    4
    0
    0
    NECK PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    NIGHT CRAMPS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    NIGHT LOWER LIMBS CRAMPS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    PAIN IN EXTREMITY
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    1
    0
    0
    SCAPULA PAIN
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    ARTERITIS INFECTIVE
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    BRONCHIAL INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    1
    0
    0
    LUNG INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    OPPORTUNISTIC INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    SEPSIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    SINUSITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    SYSTEMIC NOT CONTROLLED INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0
    TRACHEITIS
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    0
    0
    UPPER RESPIRATORY INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 44 (4.55%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    2
    0
    0
    URINARY TRACT INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    0
    1
    WOUND INFECTION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    2
    Metabolism and nutrition disorders
    ANOREXIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    3 / 25 (12.00%)
    12 / 44 (27.27%)
    3 / 9 (33.33%)
    9 / 22 (40.91%)
         occurrences all number
    3
    18
    3
    14
    DEHYDRATION
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    1 / 9 (11.11%)
    0 / 22 (0.00%)
         occurrences all number
    0
    0
    1
    0
    HYPERALBUMINEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    HYPERCALCEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    0
    0
    1
    HYPERGLYCEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 44 (0.00%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    0
    0
    HYPOCALCEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    1
    2
    0
    0
    HYPOKALEMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    2
    0
    1
    HYPONATREMIA
    alternative dictionary used: NCI-CTCAE 4.0
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 44 (2.27%)
    0 / 9 (0.00%)
    0 / 22 (0.00%)
         occurrences all number
    0
    1
    0
    0

    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.
    Since the study did not reach the targeted statistical power for the final analysis of MTC cohort, no inferential tests were performed.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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