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    Clinical Trial Results:
    A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    		 2012-003201-96
    Trial protocol
    		 NL   ES  
    Global end of trial date
    03 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Aug 2016
    First version publication date
    07 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    14789
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01788566
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Alias: I4X-MC-JFCK, Trial Number: 14789
    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, 1 877-CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877-285-4559,
    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
    03 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.
    Protection of trial subjects
    “This study was conducted in accordance with International Conference on 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
    12 Mar 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Netherlands: 5
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Taiwan: 8
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    Korea, Republic of: 3
    Worldwide total number of subjects
    61
    EEA total number of subjects
    33
    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)
    28
    From 65 to 84 years
    33
    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
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Gemcitabine + Cisplatin + Necitumumab
    Arm description
    		 Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle. Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles. Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gemcitabine
    Investigational medicinal product code
    Other name
    Gemzar®, LY188011
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.

    Investigational medicinal product name
    Cisplatin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.

    Investigational medicinal product name
    Necitumumab
    Investigational medicinal product code
    Other name
    IMC-1IF8, LY3012211, Portrazza®
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.

    Number of subjects in period 1
    		Gemcitabine + Cisplatin + Necitumumab
    Started
    61
    Completed
    53
    Not completed
    8
         Adverse event, serious fatal
    4
         Clinical Progressive Disease
    3
         Adverse event, non-fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gemcitabine + Cisplatin + Necitumumab
    Reporting group description
    		 Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle. Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles. Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.

    Reporting group values
    		 Gemcitabine + Cisplatin + Necitumumab Total
    Number of subjects
    		 61 61
    Age Categorical
    Units: participants
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 28 28
        >=65 years
    		 33 33
    Gender, Male/Female
    Units: participants
        Female
    		 12 12
        Male
    		 49 49
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 48 48
        Asian
    		 11 11
        Black or African American
    		 1 1
        Missing
    		 1 1
    Region of Enrollment
    Units: Subjects
        Canada
    		 5 5
        Netherlands
    		 5 5
        United States
    		 11 11
        Taiwan
    		 8 8
        Mexico
    		 1 1
        France
    		 3 3
        Spain
    		 25 25
        Korea, Republic of
    		 3 3

    End points

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    End points reporting groups
    Reporting group title
    Gemcitabine + Cisplatin + Necitumumab
    Reporting group description
    		 Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle. Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles. Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.

    Primary: Percentage of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)

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    End point title
    		 Percentage of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR) [1]
    End point description
    ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a >30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
    End point type
    Primary
    End point timeframe
    Baseline to Measured Progressive Disease (up to 17 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: The ORR and its Exact 95% confidence intervals were estimated.
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    54 [2]
    Units: Percentage of participants
        number (confidence interval 95%)
    48.1 (34.34 to 62.16)
    Notes
    [2] - All participants who received any amount of study treatment and had evaluable radiographic data.
    No statistical analyses for this end point

    Secondary: Overall Survival (OS)

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    End point title
    		 Overall Survival (OS)
    End point description
    Overall survival (OS) duration is defined from the date of first dose of study drug to the date of death from any cause. OS was estimated by the Kaplan-Meier method. For participants who were not known to have died as of the data cut-off date, OS was censored at the date of last contact prior to the data cutoff date.
    End point type
    Secondary
    End point timeframe
    Baseline to Death from Any Cause (up to 17 Months)
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    61 [3]
    Units: months
        median (confidence interval 95%)
    11.7 (7.59 to 99999)
    Notes
    [3] - The 95% confidence interval upper limit was not calculable due to the censored data at data cutoff.
    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 defined as the time from the date of first dose of study drug until objective progressive disease (PD) or death for any cause. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions was also considered progression. For participants not known to have died as of the data cut-off date and who do not have objective PD, PFS will be censored at the date of the last complete radiographic assessment.
    End point type
    Secondary
    End point timeframe
    Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    61
    Units: months
        median (confidence interval 95%)
    5.6 (3.68 to 6.87)
    No statistical analyses for this end point

    Secondary: Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]

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    End point title
    		 Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]
    End point description
    DCR is best overall response of SD, PR or CR. According to RECIST v1.1, PR defined as a ≥30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Percentage of participants who achieved disease control = (those participants counted in the denominator with a best tumor response of SD, PR, or CR)/(the same denominator as for ORR)*100.
    End point type
    Secondary
    End point timeframe
    Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    54 [4]
    Units: percentage of participants
        number (confidence interval 95%)
    81.5 (68.57 to 90.75)
    Notes
    [4] - All participants who received any amount of study treatment and had evaluable radiographic data.
    No statistical analyses for this end point

    Secondary: Percent Change in Tumor Size (CTS)

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    End point title
    		 Percent Change in Tumor Size (CTS)
    End point description
    CTS is defined as maximum percent improvement from baseline in the sum of target lesions.
    End point type
    Secondary
    End point timeframe
    Baseline until Measured Progressive Disease (up to 17 Months)
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    61
    Units: percent change
        arithmetic mean (standard deviation)
    39.68 ( 21.296 )
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab

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    End point title
    		 Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
    End point description
    Pre-infusion Minimum Concentration (Cmin) and post-infusion (Cmax) necitumumab serum concentration
    End point type
    Secondary
    End point timeframe
    Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    61
    Units: micrograms/milliliter (ug/ml)
    geometric mean (geometric coefficient of variation)
        Predose Cycle 1 Day 8
    70.8 ( 36.7 )
        Predose Cycle 2 Day 1
    67.5 ( 78 )
        Predose Cycle 3 Day 1
    106 ( 36.6 )
        Predose Cycle 4 Day 1
    115 ( 43.9 )
        Predose Cycle 5 Day 1
    141 ( 62.3 )
        Predose Cycle 6 Day 1
    126 ( 34.2 )
        EOI Cycle 1 Day 1
    266 ( 24.8 )
        EOI Cycle 3 Day 1
    352 ( 29.5 )
        EOI Cycle 5 Day 1
    360 ( 29.2 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Necitumumab Antibodies

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    End point title
    		 Number of Participants with Anti-Necitumumab Antibodies
    End point description
    A participant was considered to have an anti-necitumumab antibody response if anti-drug antibodies (ADA) were detected at any time point. Treatment emergent antibodies were defined as any anti-necitumumab antibody titer equal to or greater than 4-fold the participant's baseline titer.
    End point type
    Secondary
    End point timeframe
    Baseline up to 30 Days Post Last Infusion (up to 17 Months)
    End point values
    		 Gemcitabine + Cisplatin + Necitumumab
    Number of subjects analysed
    61
    Units: participants
    number (not applicable)
        Number of Participants with 1 Positive Titer
    9
        Treatment Emergent Antibody Positive
    4
        Neutralizing Antibody Detected
    3
    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
    I4X-MC-JFCK
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Necitumumab + Gemcitabine + Cisplatin
    Reporting group description
    		 -

    Serious adverse events
    		 Necitumumab + Gemcitabine + Cisplatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    33 / 61 (54.10%)
         number of deaths (all causes)
    7
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    malignant neoplasm progression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    tumour associated fever
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    aortic thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    orthostatic hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    superior vena cava syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         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 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute interstitial pneumonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    acute respiratory failure
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    atelectasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    haemoptysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    pulmonary embolism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    pulmonary haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    respiratory distress
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    confusional state
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    conduct disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    accidental overdose
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pulmonary radiation injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    cardiac tamponade
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Nervous system disorders
    ischaemic stroke
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    febrile neutropenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    duodenal perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    enteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    gastric perforation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    intestinal ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    flank pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    catheter site abscess
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    clostridium difficile infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    neutropenic sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences causally related to treatment / all
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    pneumonia haemophilus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pseudomembranous colitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         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 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    hypercalcaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    hypomagnesaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Necitumumab + Gemcitabine + Cisplatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    61 / 61 (100.00%)
    Vascular disorders
    aortic thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    embolism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    haematoma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hypertension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    5
    hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    jugular vein distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    jugular vein thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    orthostatic hypotension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    peripheral artery thrombosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    peripheral venous disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    raynaud's phenomenon
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    superior vena cava syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    25 / 61 (40.98%)
         occurrences all number
    83
    axillary pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    chills
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    face oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    fatigue
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    22 / 61 (36.07%)
         occurrences all number
    39
    feeling cold
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    gait disturbance
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    general physical health deterioration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    influenza like illness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    infusion site extravasation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    infusion site pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    infusion site urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    malaise
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    5
    mucosal dryness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    4
    mucosal inflammation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    9
    non-cardiac chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    8
    oedema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    oedema peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 61 (9.84%)
         occurrences all number
    7
    pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    pyrexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 61 (19.67%)
         occurrences all number
    17
    Immune system disorders
    hypersensitivity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [1]
    1 / 49 (2.04%)
         occurrences all number
    1
    testicular pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [2]
    1 / 49 (2.04%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    acute interstitial pneumonitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    atelectasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    bronchospasm
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    catarrh
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    4
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    17 / 61 (27.87%)
         occurrences all number
    24
    dysphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    dyspnoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    16 / 61 (26.23%)
         occurrences all number
    23
    epistaxis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    8
    haemoptysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 61 (9.84%)
         occurrences all number
    12
    hiccups
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    5
    nasal congestion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    nasal dryness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    oropharyngeal discomfort
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    pleural effusion
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    pleuritic pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    productive cough
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 61 (14.75%)
         occurrences all number
    14
    pulmonary embolism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    rhinorrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    confusional state
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    delirium
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    depression
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    insomnia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 61 (19.67%)
         occurrences all number
    14
    irritability
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    blood bilirubin increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    blood creatinine increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    blood urea increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    fibrin d dimer increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    glomerular filtration rate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    haemoglobin decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    lymphocyte count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    lymphocyte count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    neutrophil count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    11
    platelet count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    11
    platelet count increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    respiratory rate increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    troponin i increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    weight decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 61 (29.51%)
         occurrences all number
    24
    weight increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    5
    white blood cell count decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    Injury, poisoning and procedural complications
    fall
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    fracture
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    infusion related reaction
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    Cardiac disorders
    myocardial ischaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    palpitations
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    sinus tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    tachycardia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    Nervous system disorders
    aphasia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    aphonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    ataxia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    cerebrovascular accident
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dizziness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    14 / 61 (22.95%)
         occurrences all number
    17
    dysaesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dysarthria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dysgeusia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 61 (13.11%)
         occurrences all number
    8
    headache
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 61 (16.39%)
         occurrences all number
    12
    ischaemic stroke
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    lethargy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    neuralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    10
    neurotoxicity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    paraesthesia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    8
    peripheral motor neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    4
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    syncope
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    tremor
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    15 / 61 (24.59%)
         occurrences all number
    38
    iron deficiency anaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    leukopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    6
    neutropenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    19 / 61 (31.15%)
         occurrences all number
    51
    thrombocytopenia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    10 / 61 (16.39%)
         occurrences all number
    20
    Ear and labyrinth disorders
    deafness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hearing impaired
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    hypoacusis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    ototoxicity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    14
    tinnitus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    4
    vertigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Eye disorders
    blepharitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    cataract
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dry eye
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    growth of eyelashes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    lacrimation increased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    visual acuity reduced
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    abdominal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 61 (13.11%)
         occurrences all number
    10
    abdominal pain upper
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    5
    cheilitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    constipation
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    20 / 61 (32.79%)
         occurrences all number
    25
    diarrhoea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    18 / 61 (29.51%)
         occurrences all number
    29
    dry mouth
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dyspepsia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    6
    dysphagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    7
    gastrointestinal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    lip dry
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    mouth ulceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    nausea
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    45 / 61 (73.77%)
         occurrences all number
    79
    odynophagia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    oesophageal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    oesophagitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    rectal haemorrhage
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    retching
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    stomatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    21 / 61 (34.43%)
         occurrences all number
    44
    vomiting
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    22 / 61 (36.07%)
         occurrences all number
    39
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    alopecia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    9 / 61 (14.75%)
         occurrences all number
    10
    decubitus ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dermatitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dermatitis acneiform
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 61 (19.67%)
         occurrences all number
    17
    dry skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 61 (19.67%)
         occurrences all number
    25
    erythema
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hair colour changes
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hair disorder
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hirsutism
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [3]
    1 / 12 (8.33%)
         occurrences all number
    1
    hypertrichosis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    nail dystrophy
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    onycholysis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    pain of skin
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    palmar-plantar erythrodysaesthesia syndrome
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    penile ulceration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [4]
    1 / 49 (2.04%)
         occurrences all number
    1
    pruritus
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    6
    rash
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    28 / 61 (45.90%)
         occurrences all number
    109
    rash generalised
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    rash maculo-papular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    5
    rash vesicular
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    scab
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    skin fissures
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 61 (13.11%)
         occurrences all number
    15
    skin toxicity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    skin ulcer
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    urticaria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    11
    xeroderma
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    cystitis noninfective
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    dysuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    haematuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    micturition frequency decreased
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    proteinuria
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    urinary incontinence
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    urinary retention
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    6
    arthritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    back pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    4 / 61 (6.56%)
         occurrences all number
    6
    flank pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    groin pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    muscle spasms
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    muscular weakness
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    5
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    musculoskeletal pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    myalgia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    neck pain
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    pain in extremity
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    7 / 61 (11.48%)
         occurrences all number
    7
    Infections and infestations
    adenoviral conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    bronchitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    candida infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    clostridium difficile infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    conjunctivitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 61 (9.84%)
         occurrences all number
    11
    dermatophytosis of nail
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    device related infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    folliculitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    gastroenteritis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    genital infection fungal
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    herpes virus infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    impetigo
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    influenza
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    2
    nail infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    4
    nasopharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    oral candidiasis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    paronychia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    12 / 61 (19.67%)
         occurrences all number
    40
    pharyngitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    pneumonia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    3
    rhinitis
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    scrotal infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed [5]
    1 / 49 (2.04%)
         occurrences all number
    1
    skin infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    3
    soft tissue infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    upper respiratory tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    urinary tract infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    6 / 61 (9.84%)
         occurrences all number
    6
    viral infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    wound infection
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    cachexia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    decreased appetite
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    35 / 61 (57.38%)
         occurrences all number
    52
    dehydration
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    5 / 61 (8.20%)
         occurrences all number
    8
    hypercalcaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hyperglycaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    5
    hyperkalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    3 / 61 (4.92%)
         occurrences all number
    4
    hypermagnesaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hypernatraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    hypoalbuminaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    2
    hypocalcaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    11
    hypokalaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    8 / 61 (13.11%)
         occurrences all number
    19
    hypomagnesaemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    20 / 61 (32.79%)
         occurrences all number
    45
    hyponatraemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    2 / 61 (3.28%)
         occurrences all number
    3
    hypophosphataemia
    alternative dictionary used: MedDRA 16.0
         subjects affected / exposed
    1 / 61 (1.64%)
         occurrences all number
    1
    Notes
    [1] - 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.
    [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.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2012
    I4X-MC-JFCK(a) Reduced patients number, removed control arm, disconnected from JFCL.

    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
    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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