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    Clinical Trial Results:
    A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

    Summary
    EudraCT number
    2004-003116-33
    Trial protocol
    DE  
    Global end of trial date
    29 Jan 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    20030185
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00094861
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Swedish Orphan Biovitrum AB
    Sponsor organisation address
    Tomtebodavägen 23A, Stockholm, Sweden, 112 76
    Public contact
    Medical Information, Swedish Orphan Biovitrum AB, +46 86972000, info@sobi.com
    Scientific contact
    Medical Information, Swedish Orphan Biovitrum AB, +46 86972000, info@sobi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jan 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of palifermin administered at single weekly doses of 180 μg/kg in reducing the incidence of dysphagia (grade ≥ 2) induced by concurrent chemoradiotherapy (CT/RT) followed by consolidation chemotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC).
    Protection of trial subjects
    This study was conducted in accordance with US Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 Jan 2005
    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
    France: 2
    Country: Number of subjects enrolled
    Germany: 24
    Country: Number of subjects enrolled
    United States: 46
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Poland: 11
    Worldwide total number of subjects
    95
    EEA total number of subjects
    49
    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)
    53
    From 65 to 84 years
    42
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted in 42 sites globally with evaluable patients in 24 sites. 17 in the Unites States, 2 in Germany, 2 in Poland, 2 in Spain and 1 in France.

    Pre-assignment
    Screening details
    Study subjects were screened within a period up to 6 weeks before study randomization. Randomization to placebo or active treatment occured within 48 hours before the planned dose of investigational product.

    Period 1
    Period 1 title
    Acute phase
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    A registration call was made to the IVRS 48 hours before the first dose of investigational product. At the completion of this call, a randomization number and a drug box number was assigned by the IVRD. From this point on, the subject was enrolled to the study and assignes to 1 of the 2 treatment groups.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo was given as subcutaneous bolus injections.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was given as subcutaneous bolus injections. Placebo was presented as lyophilized white powder in 6.25 mg single-dose vials to be reconstituted with 1.2 ml of sterile water for injection. The reconstituted solution contained 10 mM histidin (pH6.5), 4 % mannitol, 2 % sucrose, 0.010 % polysorbate 20 and no preservatives. Injections were to be given as single weekly doses before the initiation of concurrent chemoradiotherapy, and during weeks 1 through 6 after the last dose of radiation therapy of the week (a total of 7 doses).

    Arm title
    Palifermin
    Arm description
    Kepivance was given as subcutaneous bolus injections.
    Arm type
    Experimental

    Investigational medicinal product name
    Palifermin
    Investigational medicinal product code
    Other name
    Kepivance
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Palifermin was given as subcutaneous bolus injections. Palifermin was presented as lyophilized white powder in 6.25 mg single-dose vials to be reconstituted with 1.2 ml of sterile water for injection. The reconstituted solution contained 5 mg/mL (± 0.5 mg/mL) palifermin, 10 mM histidin (pH6.5), 4 % mannitol, 2 % sucrose, 0.010 % polysorbate 20 and no preservatives. Injections were to be given as single weekly doses before the initiation of concurrent chemoradiotherapy, and during weeks 1 through 6 after the last dose of radiation therapy of the week (a total of 7 doses).

    Number of subjects in period 1
    Placebo Palifermin
    Started
    46
    49
    Completed
    28
    40
    Not completed
    18
    9
         Administrative reason
             1
             1
         Other
             3
             -
         Adverse event, serious fatal
             4
             2
         Adverse event, non-fatal
             5
             2
         Consent withdrawn by subject
             5
             3
         Lost to follow-up
             -
             1
    Period 2
    Period 2 title
    Long-term follow up
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects who received placebo during the active phase of the study.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    Palifermin
    Arm description
    Subjects who received palifermin during the active phase of the study.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    Placebo Palifermin
    Started
    28
    40
    Completed
    12
    8
    Not completed
    34
    40
         Death
             32
             37
         Adverse event, serious fatal
             1
             1
         Lost to follow-up
             1
             2
    Joined
    18
    8
         Subjects not completed Period1 counted in Period2
             18
             8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was given as subcutaneous bolus injections.

    Reporting group title
    Palifermin
    Reporting group description
    Kepivance was given as subcutaneous bolus injections.

    Reporting group values
    Placebo Palifermin Total
    Number of subjects
    46 49 95
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    25 28 53
        From 65-84 years
    21 21 42
    Gender categorical
    Units: Subjects
        Female
    14 15 29
        Male
    32 34 66
    Subject analysis sets

    Subject analysis set title
    Placebo - safety subset
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (placebo) in the in the active phase

    Subject analysis set title
    Palifermin - safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (palifermin) in the in the active phase

    Subject analysis set title
    placebo - full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received all 7 investigational product doses (placebo).

    Subject analysis set title
    Palifermin - full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received all 7 investigational product doses (palifermin).

    Subject analysis set title
    Placebo - LTFU analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received placebo during the active phase of the study and were followed in the long term follow up phase.

    Subject analysis set title
    Palifermin - LTFU analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received palifermin during the active phase of the study and were followed in the long term follow up phase.

    Subject analysis sets values
    Placebo - safety subset Palifermin - safety analysis set placebo - full analysis set Palifermin - full analysis set Placebo - LTFU analysis set Palifermin - LTFU analysis set
    Number of subjects
    46
    48
    46
    49
    46
    48
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    25
    28
    25
    28
    25
    28
        From 65-84 years
    21
    20
    21
    21
    21
    20
    Age continuous
    Units:
        
    ±
    ±
    ±
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    14
    15
    14
    15
    14
    15
        Male
    32
    33
    32
    34
    32
    33

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo was given as subcutaneous bolus injections.

    Reporting group title
    Palifermin
    Reporting group description
    Kepivance was given as subcutaneous bolus injections.
    Reporting group title
    Placebo
    Reporting group description
    Subjects who received placebo during the active phase of the study.

    Reporting group title
    Palifermin
    Reporting group description
    Subjects who received palifermin during the active phase of the study.

    Subject analysis set title
    Placebo - safety subset
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (placebo) in the in the active phase

    Subject analysis set title
    Palifermin - safety analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects receiving at least one dose of IMP (palifermin) in the in the active phase

    Subject analysis set title
    placebo - full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received all 7 investigational product doses (placebo).

    Subject analysis set title
    Palifermin - full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Subjects who received all 7 investigational product doses (palifermin).

    Subject analysis set title
    Placebo - LTFU analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received placebo during the active phase of the study and were followed in the long term follow up phase.

    Subject analysis set title
    Palifermin - LTFU analysis set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects who received palifermin during the active phase of the study and were followed in the long term follow up phase.

    Primary: Incidence of dysphagia (grade ≥ 2)

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    End point title
    Incidence of dysphagia (grade ≥ 2)
    End point description
    Subjects underwent acute dysphagia assessments which were graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale twice weekly during weeks 1 through 7, and twice weekly thereafter (weeks 8 through 12) and once weekly after week 12 until dysphagia resolved to grade ≤ 1 but not beyond week 16.
    End point type
    Primary
    End point timeframe
    Baseline until week 16
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    46
    49
    Units: Number of patients
        Yes
    32
    30
        No
    13
    18
        No assessment
    1
    1
    Statistical analysis title
    Incidence of Grade 2 or Greater Dysphagia
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.355
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.09
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.28
         upper limit
    0.1

    Secondary: Duration (days) of grade ≥ 2 dysphagia

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    End point title
    Duration (days) of grade ≥ 2 dysphagia
    End point description
    End point type
    Secondary
    End point timeframe
    Duration of dysphagia was calculated from the onset of grade ≥ 2 dysphagia to resolution (toxicity grade reduced to 0 or 1) of this event.
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    46
    49
    Units: days
        arithmetic mean (standard deviation)
    32.4 ± 30.1
    25.3 ± 28
    Statistical analysis title
    Duration of Grade 2 or greater dysphagia
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3189
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Mean difference (final values)
    Point estimate
    -7.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.2
         upper limit
    4.5

    Secondary: Maximum severity of dysphagia

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    End point title
    Maximum severity of dysphagia
    End point description
    Subjects underwent acute dysphagia assessments which were graded using the Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) dysphagia scale twice weekly during weeks 1 through 7, and twice weekly thereafter (weeks 8 through 12) and once weekly after week 12 until dysphagia resolved to grade ≤ 1 but not beyond week 16.
    End point type
    Secondary
    End point timeframe
    From baseline until week 16.
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    45
    48
    Units: grade
        arithmetic mean (standard deviation)
    1.9 ± 1
    1.8 ± 0.9
    Statistical analysis title
    Maximum severity of dysphagia
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    93
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5086
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.5
         upper limit
    0.3

    Secondary: Maximal ECOG Status Increase From Baseline Through Week 12

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    End point title
    Maximal ECOG Status Increase From Baseline Through Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    Twice weekly from baseline until week 12
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    44
    46
    Units: ECOG status
        arithmetic mean (standard deviation)
    1.5 ± 1.3
    0.9 ± 1.1
    Statistical analysis title
    Maximal ECOG status increase from baseline
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    90
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0621
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Maximal Weight Loss From Baseline Through Week 12

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    End point title
    Maximal Weight Loss From Baseline Through Week 12
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 12
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    42
    45
    Units: kg
        arithmetic mean (standard deviation)
    4.63 ± 4.13
    5.44 ± 4.33
    Statistical analysis title
    Maximal body weight loss
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0763
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Incidence of unplanned breaks in RT

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    End point title
    Incidence of unplanned breaks in RT
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 6 or 7
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    46
    49
    Units: number
        Yes
    15
    9
        No
    29
    38
        Did not receive RT
    2
    2
    Statistical analysis title
    Incidence of unplanned breaks in RT
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1115
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    -0.15
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.33
         upper limit
    0.03

    Secondary: Incidence of hospitalization

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    End point title
    Incidence of hospitalization
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 16
    End point values
    placebo - full analysis set Palifermin - full analysis set
    Number of subjects analysed
    46
    49
    Units: incidence
        yes
    31
    34
        no
    15
    15
    Statistical analysis title
    Incidence of hospitalization
    Comparison groups
    placebo - full analysis set v Palifermin - full analysis set
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8639
    Method
    Cochran-Mantel-Haenszel
    Parameter type
    Risk difference (RD)
    Point estimate
    0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.16
         upper limit
    0.2

    Secondary: incidence of serum anti-palifermin antibody formation

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    End point title
    incidence of serum anti-palifermin antibody formation
    End point description
    End point type
    Secondary
    End point timeframe
    From baselinte to week 12
    End point values
    Placebo - safety subset Palifermin - safety analysis set
    Number of subjects analysed
    32
    43
    Units: number of patients
        yes
    0
    0
        no
    32
    43
    No statistical analyses for this end point

    Secondary: Tumor progression or Recurrence of Primary Disease

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    End point title
    Tumor progression or Recurrence of Primary Disease
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline until death, lost to follow up or study end
    End point values
    Placebo - LTFU analysis set Palifermin - LTFU analysis set
    Number of subjects analysed
    46
    48
    Units: number
        yes
    29
    33
    No statistical analyses for this end point

    Secondary: Other malignancy

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    End point title
    Other malignancy
    End point description
    End point type
    Secondary
    End point timeframe
    From end of treatment until death, lost to follow up or study end.
    End point values
    Placebo - LTFU analysis set Palifermin - LTFU analysis set
    Number of subjects analysed
    46
    48
    Units: number
        yes
    0
    2
    No statistical analyses for this end point

    Other pre-specified: Second primary tumors

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    End point title
    Second primary tumors
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From end of treatment until death, lost to follow up or study end.
    End point values
    Placebo - LTFU analysis set Palifermin - LTFU analysis set
    Number of subjects analysed
    46
    48
    Units: number
        yes
    2
    2
    No statistical analyses for this end point

    Other pre-specified: Death

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    End point title
    Death
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From baseline until death, lost to follow up or study end.
    End point values
    Placebo - LTFU analysis set Palifermin - LTFU analysis set
    Number of subjects analysed
    46
    48
    Units: number
        yes
    33
    38
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to Week 12
    Adverse event reporting additional description
    A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    palifermin
    Reporting group description
    -

    Reporting group title
    placebo
    Reporting group description
    -

    Serious adverse events
    palifermin placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 48 (43.75%)
    30 / 46 (65.22%)
         number of deaths (all causes)
    2
    5
         number of deaths resulting from adverse events
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Embolism
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Death
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Performance status decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tracheal obstruction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation oesophagitis
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Weight decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial obstruction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Pancytopenia
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    7 / 48 (14.58%)
    5 / 46 (10.87%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colonic pseudo-obstruction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal hypomotility
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    4 / 48 (8.33%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 48 (0.00%)
    4 / 46 (8.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute prerenal failure
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 48 (2.08%)
    4 / 46 (8.70%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorexia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Respiratory moniliasis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 46 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    palifermin placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    48 / 48 (100.00%)
    45 / 46 (97.83%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    5 / 48 (10.42%)
    0 / 46 (0.00%)
         occurrences all number
    7
    0
    Thrombophlebitis
         subjects affected / exposed
    4 / 48 (8.33%)
    0 / 46 (0.00%)
         occurrences all number
    4
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    7 / 48 (14.58%)
    4 / 46 (8.70%)
         occurrences all number
    7
    5
    Asthenia
         subjects affected / exposed
    9 / 48 (18.75%)
    5 / 46 (10.87%)
         occurrences all number
    12
    9
    Fatigue
         subjects affected / exposed
    19 / 48 (39.58%)
    14 / 46 (30.43%)
         occurrences all number
    34
    21
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 46 (0.00%)
         occurrences all number
    3
    0
    Pyrexia
         subjects affected / exposed
    8 / 48 (16.67%)
    9 / 46 (19.57%)
         occurrences all number
    9
    10
    Pain
         subjects affected / exposed
    2 / 48 (4.17%)
    3 / 46 (6.52%)
         occurrences all number
    2
    4
    Oedema peripheral
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 46 (8.70%)
         occurrences all number
    4
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 48 (6.25%)
    6 / 46 (13.04%)
         occurrences all number
    3
    6
    Insomnia
         subjects affected / exposed
    8 / 48 (16.67%)
    9 / 46 (19.57%)
         occurrences all number
    8
    9
    Depression
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 46 (8.70%)
         occurrences all number
    2
    4
    Injury, poisoning and procedural complications
    Radiation skin injury
         subjects affected / exposed
    10 / 48 (20.83%)
    6 / 46 (13.04%)
         occurrences all number
    17
    10
    Investigations
    Weight decreased
         subjects affected / exposed
    6 / 48 (12.50%)
    7 / 46 (15.22%)
         occurrences all number
    8
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    27 / 48 (56.25%)
    21 / 46 (45.65%)
         occurrences all number
    42
    31
    Leukopenia
         subjects affected / exposed
    18 / 48 (37.50%)
    8 / 46 (17.39%)
         occurrences all number
    39
    22
    Neutropenia
         subjects affected / exposed
    13 / 48 (27.08%)
    11 / 46 (23.91%)
         occurrences all number
    26
    27
    Thrombocytopenia
         subjects affected / exposed
    10 / 48 (20.83%)
    5 / 46 (10.87%)
         occurrences all number
    23
    11
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    19 / 48 (39.58%)
    12 / 46 (26.09%)
         occurrences all number
    26
    14
    Dyspnoea
         subjects affected / exposed
    12 / 48 (25.00%)
    8 / 46 (17.39%)
         occurrences all number
    13
    8
    Dysphonia
         subjects affected / exposed
    9 / 48 (18.75%)
    3 / 46 (6.52%)
         occurrences all number
    9
    3
    Pharyngolaryngeal pain
         subjects affected / exposed
    5 / 48 (10.42%)
    11 / 46 (23.91%)
         occurrences all number
    7
    12
    Hiccups
         subjects affected / exposed
    3 / 48 (6.25%)
    2 / 46 (4.35%)
         occurrences all number
    3
    2
    Haemoptysis
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 46 (0.00%)
         occurrences all number
    3
    0
    Epistaxis
         subjects affected / exposed
    6 / 48 (12.50%)
    4 / 46 (8.70%)
         occurrences all number
    6
    4
    Nervous system disorders
    Hypoaesthesia
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    4
    Neuropathy peripheral
         subjects affected / exposed
    4 / 48 (8.33%)
    0 / 46 (0.00%)
         occurrences all number
    5
    0
    Headache
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 46 (6.52%)
         occurrences all number
    4
    3
    Dysgeusia
         subjects affected / exposed
    8 / 48 (16.67%)
    3 / 46 (6.52%)
         occurrences all number
    8
    3
    Dizziness
         subjects affected / exposed
    6 / 48 (12.50%)
    5 / 46 (10.87%)
         occurrences all number
    7
    7
    Paraesthesia
         subjects affected / exposed
    3 / 48 (6.25%)
    2 / 46 (4.35%)
         occurrences all number
    3
    2
    Peripheral sensory neuropathy
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 46 (6.52%)
         occurrences all number
    7
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 48 (6.25%)
    4 / 46 (8.70%)
         occurrences all number
    3
    6
    Diarrhoea
         subjects affected / exposed
    9 / 48 (18.75%)
    9 / 46 (19.57%)
         occurrences all number
    12
    10
    Constipation
         subjects affected / exposed
    14 / 48 (29.17%)
    13 / 46 (28.26%)
         occurrences all number
    23
    13
    Dry mouth
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 46 (2.17%)
         occurrences all number
    4
    1
    Dyspepsia
         subjects affected / exposed
    8 / 48 (16.67%)
    7 / 46 (15.22%)
         occurrences all number
    12
    7
    Nausea
         subjects affected / exposed
    25 / 48 (52.08%)
    23 / 46 (50.00%)
         occurrences all number
    34
    27
    Oesophagitis
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 46 (2.17%)
         occurrences all number
    9
    1
    Vomiting
         subjects affected / exposed
    10 / 48 (20.83%)
    11 / 46 (23.91%)
         occurrences all number
    13
    22
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 46 (2.17%)
         occurrences all number
    4
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 48 (4.17%)
    3 / 46 (6.52%)
         occurrences all number
    3
    3
    Alopecia
         subjects affected / exposed
    10 / 48 (20.83%)
    6 / 46 (13.04%)
         occurrences all number
    13
    6
    Rash
         subjects affected / exposed
    4 / 48 (8.33%)
    5 / 46 (10.87%)
         occurrences all number
    5
    8
    Erythema
         subjects affected / exposed
    8 / 48 (16.67%)
    2 / 46 (4.35%)
         occurrences all number
    9
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 48 (10.42%)
    5 / 46 (10.87%)
         occurrences all number
    5
    5
    Musculoskeletal pain
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 46 (2.17%)
         occurrences all number
    3
    1
    Myalgia
         subjects affected / exposed
    6 / 48 (12.50%)
    5 / 46 (10.87%)
         occurrences all number
    12
    5
    Arthralgia
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 46 (6.52%)
         occurrences all number
    8
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 46 (6.52%)
         occurrences all number
    1
    5
    Neck pain
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 46 (6.52%)
         occurrences all number
    1
    4
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    10 / 48 (20.83%)
    6 / 46 (13.04%)
         occurrences all number
    18
    7
    Hypocalcaemia
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 46 (6.52%)
         occurrences all number
    3
    3
    Hypokalaemia
         subjects affected / exposed
    8 / 48 (16.67%)
    8 / 46 (17.39%)
         occurrences all number
    8
    9
    Hypomagnesaemia
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 46 (2.17%)
         occurrences all number
    3
    2
    Anorexia
         subjects affected / exposed
    13 / 48 (27.08%)
    8 / 46 (17.39%)
         occurrences all number
    20
    10
    Hyponatraemia
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 46 (6.52%)
         occurrences all number
    0
    3
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 48 (10.42%)
    1 / 46 (2.17%)
         occurrences all number
    5
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2005
    Patients with T3N1 and T4 disease are eligible to participate in the study. The Lung Cancer Symptom Scale (LCSS) has been removed from the PRO component of the study. The imaging requirements at screening to rule out metastatic disease in the chest and abdomen have been modified. Tumor response will no longer be evaluated using RECIST criteria. Beginning with week 8, PRO assessments can be discontinued if dysphagia resolves to CTCAE v3.0 grade ≤ 1. Consolidation chemotherapy (paclitaxel and carboplatin), which is given during weeks 7 and 10, may be administered any day of the week, at the discretion of the investigator. In order to standardize the administration of radiation therapy across multiple sites, RT guidelines are provided. Laboratory assessments (hematology and chemistry) required at baseline through week 12 have been modified to ensure consistency with other studies in the palifermin clinical development program. Pneumonitis assessments, which were previously required at month 6 only, will now be required at months 6, 9, and 12. Study conduct in the US will be expanded from 12 sites to approximately 20 sites and in the EU from 8 sites to approximately 10 sites.
    03 Mar 2006
    The exclusion criterion relating to the pleural or pericardial effusion was added in Amendment #1 with the intention of excluding stage IIIb subjects with malignant pleural effusion, who have poorer prognosis, has been clarified. The prescription dose of radiation therapy has been changed from a fixed dose of 60 Gy to a range of 60-66 Gy.
    14 Feb 2008
    Clarification of secondary objective ‘To assess the effect of palifermin on treatmentrelated clinical sequelae’ and the corresponding analyses. The planned analyses of treatment-related clinical sequelae have been reduced and no longer include: incidence and cumulative dose of opioid analgesics use (morphine equivalents); duration (days) of hospitalization; incidence of percutaneous endoscopic gastrostomy (PEG)/nasogastric (NG) tube, total parenteral nutrition (TPN), and IV hydration use; incidence of infections. Removal of secondary objective ‘To assess the effect of palifermin on patient-reported outcomes (PRO)’ and the corresponding analyses. No analyses based on a PRO efficacy evaluable subset are planned.
    15 Dec 2008
    The sponsorship was transferred from Amgen Inc to Biovitrum AB.
    15 Aug 2013
    The long term follow up period was limited to up to 5 years from the last subject randomized.

    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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