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    Clinical Trial Results:
    A phase 2 study of Pemetrexed and Cisplatin plus Cetuximab followed by Pemetrexed and Cetuximab Maintenance Therapy in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB or IV) other than Predominantly Squamous Cell Histology

    Summary
    EudraCT number
    		 2008-004330-24
    Trial protocol
    		 DE   AT   NL   ES   IT   GR  
    Global end of trial date
    19 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2016
    First version publication date
    15 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H3E-MC-S104
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00867009
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: H3E-MC-S104, Trial ID: 10726
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN., United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 800-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 800-285-4559,
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN., United States, 46285
    Public contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 800-CTLilly,
    Scientific contact
    Available Mon - Fri 9 AM - 5 PM EST, Eli Lilly and Company, 1 800-285-4559,
    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
    19 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 May 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will estimate the response rate in patients with advanced or metastatic non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance treatment with pemetrexed and cetuximab.
    Protection of trial subjects
    This study was conducted in accordance with International Code of Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2009
    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
    Greece: 12
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Germany: 28
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    Italy: 26
    Worldwide total number of subjects
    113
    EEA total number of subjects
    113
    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)
    84
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No text entered

    Pre-assignment
    Screening details
    		 No text entered

    Period 1
    Period 1 title
    Induction Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pem/Cis + Cet
    Arm description
    		 Induction Therapy: 500 milligrams per meter squared (mg/m²) pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles. Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    LY231514
    Other name
    Alimta
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Erbitux
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles

    Number of subjects in period 1
    		Pem/Cis + Cet
    Started
    113
    Received at least 1 dose of study drug
    113
    Protocol Qualified (PQ) Population
    109
    Completed
    51
    Not completed
    62
         Consent withdrawn by subject
    8
         Physician decision
    3
         Death due to serious adverse event
    6
         Progressive Disease (PD)
    25
         Nonserious Adverse Event
    5
         Death due to Study Disease
    4
         Serious Adverse Event
    10
         Protocol deviation
    1
    Period 2
    Period 2 title
    Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pem/Cis + Cet
    Arm description
    		 Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles. Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    LY231514
    Other name
    Alimta
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation

    Investigational medicinal product name
    Cetuximab
    Investigational medicinal product code
    Other name
    Erbitux
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation

    Number of subjects in period 2
    		Pem/Cis + Cet
    Started
    51
    Completed
    47
    Not completed
    4
         On-going in the Study at Data Cut-off
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pem/Cis + Cet
    Reporting group description
    		 Induction Therapy: 500 milligrams per meter squared (mg/m²) pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles. Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.

    Reporting group values
    		 Pem/Cis + Cet Total
    Number of subjects
    		 113 113
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 84 84
        From 65-84 years
    		 29 29
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.15 ± 8.83 -
    Gender, Male/Female
    Units: participants
        Female
    		 41 41
        Male
    		 72 72
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 113 113
    Region of Enrollment
    Units: Subjects
        Greece
    		 12 12
        Spain
    		 25 25
        Austria
    		 6 6
        Germany
    		 28 28
        Netherlands
    		 16 16
        Italy
    		 26 26
    Eastern Co-operative Oncology Group (ECOG) Performance Status
    Classifies patients according to their functional impairment. ECOG Performance Score: 0 - Fully Active; 1 - Ambulatory, Restricted Strenuous Activity; 2 - Ambulatory, No Work Activities; 3 - Partially Confined to Bed, Limited Self Care; 4 - Completely Disabled; 5 - Death
    Units: Subjects
        0 - Fully Active
    		 56 56
        1 - Ambulatory, Restricted Strenuous Activity
    		 57 57
    Disease Stage
    Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIB - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver
    Units: Subjects
        Stage IIIB
    		 9 9
        Stage IV
    		 104 104
    Pathological Diagnosis
    Units: Subjects
        Adenocarcinoma (Adeno), Breast
    		 1 1
        Carcinoma, Adenosquamous,Lung, Predominantly Adeno
    		 1 1
        Large Cells Lung Carcinoma
    		 5 5
        Malignant Neoplasm, Adeno Lung
    		 88 88
        Non-Small Cell Lung (NSCL) Cancer
    		 9 9
        Poorly Differentiated Non-Small Cell
    		 8 8
        Missing
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    Pem/Cis + Cet
    Reporting group description
    		 Induction Therapy: 500 milligrams per meter squared (mg/m²) pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles. Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.
    Reporting group title
    Pem/Cis + Cet
    Reporting group description
    		 Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles. Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation.

    Subject analysis set title
    Received at Least One Dose of Study Drug
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants with Stage IIIB/IV non-squamous (NS) non-small cell lung cancer (NSCLC)

    Subject analysis set title
    Protocol Qualified (PQ) Population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Stage IIIB/IV NS-NSCLC, no concurrent chemotherapy, measurable disease, ≥1 dose study drug.

    Subject analysis set title
    Completed Induction Period
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants continued on the study in the Maintenance Period.

    Primary: Percentage of participants with a tumor response (objective tumor response rate)

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    End point title
    		 Percentage of participants with a tumor response (objective tumor response rate) [1]
    End point description
    Response was assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions. Tumor response is presented as a percentage (%) and is the number of participants with a CR plus PR divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100.
    End point type
    Primary
    End point timeframe
    From start of treatment until documented best response (up to 18.9 months)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics are used to represent the tumor response rate as there are no comparison groups for this single arm study. The Overall Response Rate was 38.5% of the Protocol Qualified (PQ) population with an 80% Confidence Interval (CI).
    End point values
    		 Protocol Qualified (PQ) Population
    Number of subjects analysed
    109
    Units: Percentage of participants
    number (not applicable)
        Percentage of Participants With a Tumor Response
    38.5
    No statistical analyses for this end point

    Secondary: Progression-free Survival (PFS)

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    End point title
    		 Progression-free Survival (PFS)
    End point description
    PFS is measured from study entry until disease progression, death or date of last contact. Progressive disease (PD) was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For participants not known to have died or have had objective PD as of the data cutoff date, PFS was censored at the date of the last objective progression-free disease assessment.
    End point type
    Secondary
    End point timeframe
    From start of treatment until documented disease progression or death from any cause (up to 18.9 months)
    End point values
    		 Protocol Qualified (PQ) Population
    Number of subjects analysed
    109
    Units: Months
    median (full range (min-max))
        Progression-free Survival (PFS)
    5.82 (0.03 to 18.89)
    No statistical analyses for this end point

    Secondary: The Percentage of Participants Still Living at One Year (One Year Survival Rate)

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    End point title
    		 The Percentage of Participants Still Living at One Year (One Year Survival Rate)
    End point description
    The one year survival rate is presented as percentage (%) of participants still living at one year and is the number of participants that are still alive at one year divided by the number of participants in the protocol qualified (PQ) population, which is then multiplied by 100.
    End point type
    Secondary
    End point timeframe
    One year
    End point values
    		 Protocol Qualified (PQ) Population
    Number of subjects analysed
    109
    Units: Percentage of participants
    number (not applicable)
        Percentage of Participants Still Living at 1 Year
    45
    No statistical analyses for this end point

    Secondary: The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])

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    End point title
    		 The Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
    End point description
    The DCR is presented as percentage (%) and is the number of participants with a best tumor response of CR, PR, or SD divided by the number of participants in the protocol qualified (PQ) population, then multiplied by 100. Best tumor response of CR, PR, or SD was determined from the sequence of tumor response assessments. Tumor response was assessed using RECIST criteria. CR=disappearance of all target lesions; PR=30% decrease in sum of longest diameter of target lesions; SD=small changes that do not meet above criteria.
    End point type
    Secondary
    End point timeframe
    From start of treatment until documented best tumor response (up to 18.9 months)
    End point values
    		 Protocol Qualified (PQ) Population
    Number of subjects analysed
    109
    Units: Percentage of participants
    number (not applicable)
        Percentage of participants with response
    59.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H3E-MC-S104
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Pemetrexed and Cisplatin plus Cetuximab
    Reporting group description
    		 -

    Serious adverse events
    		 Pemetrexed and Cisplatin plus Cetuximab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    61 / 113 (53.98%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    tumour pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    peripheral ischaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    thrombosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    venous thrombosis limb
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    chills
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    death
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    device occlusion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    fatigue
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 2
    mucosal inflammation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    malaise
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    obstruction
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    cytokine release syndrome
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    drug hypersensitivity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    hypersensitivity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    uterine haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [1]
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    hypoxia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    pulmonary embolism
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences causally related to treatment / all
    1 / 6
         deaths causally related to treatment / all
    0 / 2
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    haemoglobin decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    neutrophil count decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    white blood cell count decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    atrial flutter
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    intracardiac thrombus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    tachyarrhythmia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    cerebral ischaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    convulsion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    dizziness
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    hemiparesis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    leukoencephalopathy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    nerve compression
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    tremor
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    leukopenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 1
    neutropenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences causally related to treatment / all
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences causally related to treatment / all
    7 / 7
         deaths causally related to treatment / all
    0 / 1
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Eye disorders
    diplopia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    constipation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences causally related to treatment / all
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    diverticular perforation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    duodenal ulcer
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    duodenal perforation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ileus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    nausea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    stomatitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences causally related to treatment / all
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    stasis dermatitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    renal failure
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    bone pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    biliary sepsis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    catheter site infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    enterococcal sepsis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    gastroenteritis norovirus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    gangrene
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    herpes zoster
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    peritonitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    sepsis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    hypocalcaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    hypokalaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Pemetrexed and Cisplatin plus Cetuximab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    101 / 113 (89.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    basal cell carcinoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    uterine leiomyoma
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [2]
    1 / 41 (2.44%)
         occurrences all number
    1
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    flushing
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hot flush
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypertension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    hypotension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    phlebitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    phlebitis superficial
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Surgical and medical procedures
    catheter placement
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    dental implantation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    15 / 113 (13.27%)
         occurrences all number
    20
    catheter site pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    chills
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    chest pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    8
    extravasation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    feeling cold
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    fatigue
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    37 / 113 (32.74%)
         occurrences all number
    81
    facial pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    generalised oedema
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hernia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    influenza like illness
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    localised oedema
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    malaise
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    mucosal dryness
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    mucosal inflammation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    21 / 113 (18.58%)
         occurrences all number
    30
    oedema peripheral
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    12
    pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    peripheral swelling
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pyrexia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    14 / 113 (12.39%)
         occurrences all number
    19
    ulcer
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Immune system disorders
    contrast media allergy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    drug hypersensitivity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypersensitivity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    seasonal allergy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Reproductive system and breast disorders
    balanoposthitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [3]
    1 / 72 (1.39%)
         occurrences all number
    1
    erectile dysfunction
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [4]
    1 / 72 (1.39%)
         occurrences all number
    1
    menstruation irregular
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [5]
    1 / 41 (2.44%)
         occurrences all number
    1
    uterine haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [6]
    1 / 41 (2.44%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    20 / 113 (17.70%)
         occurrences all number
    24
    dyspnoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    18 / 113 (15.93%)
         occurrences all number
    28
    dysphonia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    7
    epistaxis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    7
    dyspnoea exertional
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    haemoptysis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hiccups
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    hypoxia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    laryngospasm
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    oropharyngeal pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pharyngeal ulceration
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pleuritic pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    productive cough
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pulmonary embolism
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    rhinitis allergic
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    confusional state
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    depression
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    fear
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    insomnia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    sleep disorder
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Investigations
    activated partial thromboplastin time prolonged
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    13
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    17
    blood calcium
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    blood calcium decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    blood creatinine decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    blood sodium decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    blood potassium decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    blood magnesium decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    6
    blood creatinine increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    8
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    6
    glomerular filtration rate decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    haemoglobin decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    20
    haemoglobin
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    neutrophil count decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    platelet count decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    8
    protein c increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    weight increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    white blood cell count decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    5
    weight decreased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    11
    Injury, poisoning and procedural complications
    bone contusion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    head injury
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    radiation skin injury
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    radius fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    thermal burn
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    upper limb fracture
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    vascular injury
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    wound
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    atrial fibrillation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    cardiac failure
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    cardiac fibrillation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    palpitations
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    sinus tachycardia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    tachycardia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Nervous system disorders
    ageusia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    ataxia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    cerebral ischaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    dizziness
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    15 / 113 (13.27%)
         occurrences all number
    15
    dysgeusia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    9
    dysarthria
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    headache
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    9 / 113 (7.96%)
         occurrences all number
    15
    hypogeusia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    neuralgia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    neuropathy peripheral
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    paraesthesia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    paraparesis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    12 / 113 (10.62%)
         occurrences all number
    14
    peripheral motor neuropathy
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    presyncope
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    somnolence
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    tremor
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    20 / 113 (17.70%)
         occurrences all number
    38
    febrile neutropenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    haemoglobinaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    lymphopenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    leukopenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    24 / 113 (21.24%)
         occurrences all number
    60
    neutropenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    25 / 113 (22.12%)
         occurrences all number
    72
    thrombocytopenia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    9
    Ear and labyrinth disorders
    deafness
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    ear haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    external ear pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypoacusis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    tinnitus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    vertigo
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    Eye disorders
    blepharitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    diplopia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    dry eye
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    eye oedema
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    eyelid disorder
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    lacrimation increased
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    10 / 113 (8.85%)
         occurrences all number
    12
    keratitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    ocular surface disease
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    ocular hyperaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    ulcerative keratitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    8
    abdominal distension
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    abdominal pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    8
    cheilitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    constipation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    29 / 113 (25.66%)
         occurrences all number
    33
    diarrhoea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    24 / 113 (21.24%)
         occurrences all number
    36
    dry mouth
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    dysphagia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    9
    dyspepsia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    8
    eructation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    gastritis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    9
    glossodynia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    glossitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    gastrointestinal ulcer
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    haemorrhoids
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    nausea
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    51 / 113 (45.13%)
         occurrences all number
    95
    odynophagia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    oesophagitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    rectal haemorrhage
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    stomatitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    23 / 113 (20.35%)
         occurrences all number
    38
    vomiting
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    34 / 113 (30.09%)
         occurrences all number
    58
    Hepatobiliary disorders
    cholangitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hepatic pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hyperbilirubinaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypertransaminasaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    actinic keratosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    alopecia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    10
    dermatitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    dermatitis acneiform
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    7
    dry skin
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    11 / 113 (9.73%)
         occurrences all number
    12
    erythema
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    exfoliative rash
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    erythema multiforme
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    4
    hirsutism
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [7]
    1 / 41 (2.44%)
         occurrences all number
    1
    hyperhidrosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    hypertrichosis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    intertrigo
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    nail disorder
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    6 / 113 (5.31%)
         occurrences all number
    7
    nail toxicity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    palmar-plantar erythrodysaesthesia syndrome
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    12
    pain of skin
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pruritus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    rash
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    62 / 113 (54.87%)
         occurrences all number
    88
    rash follicular
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    skin disorder
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    skin fissures
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    skin reaction
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    2
    skin hyperpigmentation
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    Renal and urinary disorders
    bladder pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    bladder spasm
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    haematuria
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    nephropathy toxic
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pollakiuria
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    renal failure
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    renal colic
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    urinary retention
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Endocrine disorders
    inappropriate antidiuretic hormone secretion
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    back pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    10 / 113 (8.85%)
         occurrences all number
    19
    bone pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    intervertebral disc space narrowing
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    muscle spasms
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    myalgia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    7 / 113 (6.19%)
         occurrences all number
    13
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    neck pain
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    pain in extremity
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    3
    trismus
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    cellulitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    cystitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    conjunctivitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    16 / 113 (14.16%)
         occurrences all number
    25
    ear infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    eye infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    folliculitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    5
    gastroenteritis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    herpes simplex
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    influenza
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    laryngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    localised infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    nail bed infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    nail infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    nasopharyngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    4
    oropharyngeal candidiasis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    oral candidiasis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    oral fungal infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    paronychia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    penile infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [8]
    1 / 72 (1.39%)
         occurrences all number
    3
    pharyngitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    pneumonia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    respiratory tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    rhinitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    sinusitis
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    3
    skin infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    2 / 113 (1.77%)
         occurrences all number
    2
    tooth infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    upper aerodigestive tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    vaginal infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed [9]
    2 / 41 (4.88%)
         occurrences all number
    2
    urinary tract infection
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    4 / 113 (3.54%)
         occurrences all number
    5
    Metabolism and nutrition disorders
    cachexia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    decreased appetite
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    21 / 113 (18.58%)
         occurrences all number
    34
    dehydration
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    fluid retention
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    8
    hyperglycaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    3 / 113 (2.65%)
         occurrences all number
    6
    hyperkalaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypernatraemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypocalcaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    12
    hypoalbuminaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    1
    hypokalaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    5 / 113 (4.42%)
         occurrences all number
    6
    hypomagnesaemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    8 / 113 (7.08%)
         occurrences all number
    8
    hyponatraemia
    alternative dictionary used: MedDRA 17.1
         subjects affected / exposed
    1 / 113 (0.88%)
         occurrences all number
    3
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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