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    Clinical Trial Results:
    A Phase II Study of Pemetrexed in Children with Recurrent Malignancies

    Summary
    EudraCT number
    2017-000095-28
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    03 Feb 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Apr 2017
    First version publication date
    16 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H3E-MC-JMHW
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00520936
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 10294
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, 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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Feb 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the response rate of pemetrexed given every 21 days for the treatment of children with relapsed or refractory osteosarcoma, Ewing's sarcoma/peripheral primitive neuroectodermal tumors (PNET), rhabdomyosarcoma, neuroblastoma, ependymoma, medulloblastoma/supratentorial PNET or non-brain stem high-grade glioma.
    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
    01 Sep 2007
    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: 11
    Country: Number of subjects enrolled
    United States: 61
    Worldwide total number of subjects
    72
    EEA total number of subjects
    0
    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)
    37
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    15
    From 65 to 84 years
    0
    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
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Osteosarcoma
    Arm description
    Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Rhabdomyosarcoma
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Neuroblastoma (Measureable Disease)
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Ependymoma
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Arm title
    Non-Brainstem High-Grade Glioma
    Arm description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
    Arm type
    Experimental

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514, Alimta
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1910 milligrams per meter squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old), intravenous (IV), for 21 days x 17 cycles

    Number of subjects in period 1
    Osteosarcoma Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Rhabdomyosarcoma Neuroblastoma (Measureable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Ependymoma Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Non-Brainstem High-Grade Glioma
    Started
    10
    11
    9
    5
    6
    10
    11
    10
    Completed
    10
    7
    7
    5
    5
    10
    7
    9
    Not completed
    0
    4
    2
    0
    1
    0
    4
    1
         Protocol deviation
    -
    1
    1
    -
    1
    -
    1
    -
         Toxicity Requiring Removal from Study
    -
    1
    -
    -
    -
    -
    2
    -
         Physician decision
    -
    2
    1
    -
    -
    -
    -
    -
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    1
    -
         Consent withdrawn by subject
    -
    -
    -
    -
    -
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Osteosarcoma
    Reporting group description
    Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)

    Reporting group title
    Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Rhabdomyosarcoma
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Neuroblastoma (Measureable Disease)
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Ependymoma
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Non-Brainstem High-Grade Glioma
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group values
    Osteosarcoma Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Rhabdomyosarcoma Neuroblastoma (Measureable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Ependymoma Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Non-Brainstem High-Grade Glioma Total
    Number of subjects
    10 11 9 5 6 10 11 10 72
    Age categorical
    Units: Subjects
    Gender, Male/Female
    Units:
        Female
    4 8 6 1 1 3 4 5 32
        Male
    6 3 3 4 5 7 7 5 40
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    0 0 2 0 0 0 0 0 2
        Asian
    0 1 0 0 0 0 0 1 2
        Black or African American
    4 0 0 2 1 1 3 3 14
        White
    4 8 7 2 4 9 8 6 48
        Other
    1 1 0 1 0 0 0 0 3
        Unknown
    1 1 0 0 1 0 0 0 3
    Region of Enrollment
    Units: Subjects
        United States
    7 7 8 5 5 9 10 10 61
        Canada
    3 4 1 0 1 1 1 0 11
    Karnofsky Performance Score
    Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. 100 - Normal no complaints; no evidence of disease 90 - Normal activity; minor signs of disease 80 - Activity with effort; some signs of disease 70 - Unable to carry on normal activity <=60 Needs increasing assistance up to Death (0)
    Units: Subjects
        100
    0 2 0 0 0 1 0 0 3
        90
    3 3 0 0 1 0 1 1 9
        80
    0 1 0 0 0 0 0 1 2
        70
    0 1 0 0 0 0 1 0 2
        50
    1 0 0 0 0 0 1 0 2
        Not Recorded
    6 4 9 5 5 9 8 8 54
    Lansky Play Score
    100=fully active, normal. 90=minor restrictions in physically strenuous activity. 80=active, but tires more quickly. 70=both greater restriction of and less time spent in play activity. 60=up and around, but minimal active play; keeps busy with quieter activities. 50=gets dressed, but lies around much of the day; no active play, able to participate in all quiet play activities. 40=mostly in bed; participates in quiet activities. 30=in bed; needs assistance even for quiet play. 20=often sleeping; play entirely limited to very passive activities. 10=No play; does not get out of bed.
    Units: Subjects
        100
    1 1 3 4 2 2 2 3 18
        90
    1 3 3 1 1 2 3 4 18
        80
    2 0 2 0 2 3 2 0 11
        70
    0 0 0 0 0 1 0 1 2
        60
    1 0 1 0 0 1 1 0 4
        50
    1 0 0 0 0 0 0 0 1
        Not Recorded
    4 7 0 0 1 1 3 2 18
    Age
    Units: Years
        arithmetic mean (standard deviation)
    14.94 ± 4.28 18.24 ± 3.35 8.74 ± 4.96 6.23 ± 2.98 9.62 ± 5.38 8.42 ± 4.59 12 ± 7.13 12.75 ± 5.15 -

    End points

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    End points reporting groups
    Reporting group title
    Osteosarcoma
    Reporting group description
    Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)

    Reporting group title
    Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Rhabdomyosarcoma
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Neuroblastoma (Measureable Disease)
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Ependymoma
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Reporting group title
    Non-Brainstem High-Grade Glioma
    Reporting group description
    Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)

    Primary: Percentage of Participants with Overall Tumor Response (Response Rate)

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    End point title
    Percentage of Participants with Overall Tumor Response (Response Rate) [1]
    End point description
    Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response = disappearance of all target lesions. Partial Response = 30% decrease in sum of longest diameter of target lesions. Response rate (percent [%])= (number of participants with complete response (CR) or partial response (PR) in stratum/number of participants in stratum)*100. Population Description: All treated participants
    End point type
    Primary
    End point timeframe
    baseline to measured progressive disease (up to 1 year)
    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 primary objective was to estimate the response rates to pemetrexed and to further define and describe the toxicities of pemetrexed. There were no responders (neither CR nor PR) in this study.
    End point values
    Osteosarcoma Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Rhabdomyosarcoma Neuroblastoma (Measureable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Ependymoma Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Non-Brainstem High-Grade Glioma
    Number of subjects analysed
    10
    11
    9
    5
    6
    10
    11
    10
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Patients with Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug

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    End point title
    Number of Patients with Adverse Events, Discontinuations, or Deaths Possibly Due to Study Drug
    End point description
    AdEERS= Adverse Event Expedited Reporting System; AE = adverse event. Patients may be counted in more than 1 category. Includes events that were considered possibly related to study drug (PRSD) as judged by the investigator. Population Description: All treated participants
    End point type
    Secondary
    End point timeframe
    every cycle (up to 2 years and 7 months)
    End point values
    Osteosarcoma Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Rhabdomyosarcoma Neuroblastoma (Measureable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Ependymoma Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Non-Brainstem High-Grade Glioma
    Number of subjects analysed
    10
    11
    9
    5
    6
    10
    11
    10
    Units: Participants
        >=1 AdEERs possibly related to study drug
    3
    2
    0
    2
    3
    2
    2
    2
        Discontinued due to AE possibly related to drug
    0
    1
    0
    0
    0
    0
    2
    0
        Died on therapy possibly related to study drug
    0
    0
    0
    0
    0
    0
    0
    0
        Died within 31 days of last dose of drug PRSD
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Pharmacogenomics - measure the response of genes related to toxicity

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    End point title
    Pharmacogenomics - measure the response of genes related to toxicity
    End point description
    The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here. Results of this optional research may be reported in the future by the Children's Oncology Group in the peer-reviewed literature. Population Description: The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrahydrofolate reductase gene and the presence of a polymorphism in the thymidylate synthase (TS) gene and/or gene promoter and toxicity were optional and will not be reported here.
    End point type
    Secondary
    End point timeframe
    baseline
    End point values
    Osteosarcoma Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors Rhabdomyosarcoma Neuroblastoma (Measureable Disease) Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable) Ependymoma Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor Non-Brainstem High-Grade Glioma
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: Correlation coefficient
        number (not applicable)
    Notes
    [2] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [3] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [4] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [5] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [6] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [7] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [8] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    [9] - The pharmacogenomics outcomes examining the correlation between the presence of the methylene tetrah
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Entire Study
    Adverse event reporting additional description
    H3E-MC-JMHW
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Pemetrexed
    Reporting group description
    -

    Serious adverse events
    Pemetrexed
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 72 (29.17%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Investigations
    ggt
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    hemorrhage, cns
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    hemoglobin
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    infection
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    infection with normal anc or grade 1
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    4 / 72 (5.56%)
         occurrences causally related to treatment / all
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    leukocytes
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    lymphopenia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    neutrophils/granulocytes
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    platelets
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    death not associated with ctcae term
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    hydrocephalus
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    mood alteration: depression
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    syncope
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    fever
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    flushing
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    pain: extremity-limb
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    nausea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    pain: tumor pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ulceration
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    rash: erythema multiforme
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    albumin, serum-low
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    calcium, serum-low
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    phosphate, serum-low
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    3 / 72 (4.17%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    potassium, serum-low
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    dyspnea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    rash/desquamation
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         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
    Pemetrexed
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 72 (13.89%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    seizure
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Cardiac disorders
    dermatology/skin - other
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    pulmonary/upper respiratory - other
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    thrombosis/thrombus/embolism
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    sodium, serum-low
    alternative dictionary used: MedDRA 11.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    infection with normal anc or grade 1
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    hypoxia
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    General disorders and administration site conditions
    fever
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    2 / 72 (2.78%)
         occurrences all number
    2
    Gastrointestinal disorders
    diarrhea
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    hemorrhage, gi: rectum
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    pain: tumor pain
    alternative dictionary used: MedDRA 12.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    Renal and urinary disorders
    hemorrhage, gu: urinary nos
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1
    renal failure
    alternative dictionary used: MedDRA 13.0
         subjects affected / exposed
    1 / 72 (1.39%)
         occurrences all number
    1

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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