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    Clinical Trial Results:
    A Phase 2 Study to Evaluate LY2603618 in Combination with Pemetrexed in Patients with Advanced or Metastatic Non-small Cell Lung Cancer

    Summary
    EudraCT number
    		 2009-013787-39
    Trial protocol
    		 IT  
    Global end of trial date
    11 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Jul 2017
    First version publication date
    30 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I2I-MC-JMMD
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00988858
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 12092
    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
    11 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to evaluate the efficacy and safety of LY2603618 in combination with pemetrexed and any side effects that might be associated with it along with determining the effects of LY2603618 in combination with pemetrexed in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC).
    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 Nov 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 24
    Country: Number of subjects enrolled
    Taiwan: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 14
    Country: Number of subjects enrolled
    Italy: 12
    Worldwide total number of subjects
    55
    EEA total number of subjects
    12
    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)
    32
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants that had progressive disease were completers.

    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
    Arm title
    		 LY2603618 and Pemetrexed
    Arm description
    		 LY2603618: 150 milligram per square meter mg/m^2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a planned minimum of 2 cycles or until disease progression Pemetrexed: 500mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a planned minimum of 2 cycles or until disease progression
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2603618
    Investigational medicinal product code
    Other name
    CHK-1 Inhibitor I
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    150 milligram per square meter (mg/m^2) intravenously on Day 2 of each 21 day cycle repeating every 21 days for a planned minimum of 2 cycles continuing until disease progression

    Investigational medicinal product name
    Pemetrexed
    Investigational medicinal product code
    Other name
    LY231514
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    500 mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a planned minimum of 2 cycles or until disease progression

    Number of subjects in period 1
    		LY2603618 and Pemetrexed
    Started
    55
    Completed
    45
    Not completed
    10
         Physician decision
    1
         Adverse event, non-fatal
    7
         Death
    1
         Sponsor Decision
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 55 55
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.2 ( 8.6 ) -
    Gender, Male/Female
    Units:
        Male
    		 34 34
        Female
    		 21 21
    Region of Enrollment
    Units: Subjects
        United States
    		 24 24
        Taiwan
    		 5 5
        Korea, Republic of
    		 14 14
        Italy
    		 12 12
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 55 55
        Unknown or Not Reported
    		 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 21 21
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 1 1
        White
    		 33 33
        More than one race
    		 0 0
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    LY2603618 and Pemetrexed
    Reporting group description
    		 LY2603618: 150 milligram per square meter mg/m^2 intravenously on Day 2 of each 21 day cycle repeating every 21 days for a planned minimum of 2 cycles or until disease progression Pemetrexed: 500mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a planned minimum of 2 cycles or until disease progression

    Primary: Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]

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    End point title
    		 Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)] [1]
    End point description
    Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. Analysis Population Description : All randomized participants who received at least 1 dose of drug.
    End point type
    Primary
    End point timeframe
    Baseline until Progressive Disease or Study Discontinuation (Up to 23 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: This is a single arm study with no comparison groups therefore statistical analyses(comparison analysis) were not conducted.
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    55
    Units: percentage of participants
        number (confidence interval 95%)
    9.1 (3.7 to 18.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)

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    End point title
    		 Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)
    End point description
    Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. Analysis Population Description : All randomized participants who received at least 1 dose of drug.
    End point type
    Secondary
    End point timeframe
    Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    55
    Units: percentage of participants
        number (confidence interval 90%)
    45.5 (33.9 to 57.4)
    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
    Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates. Analysis Population Description : All randomized participants who received at least 1 dose of drug. 9 participants were censored.
    End point type
    Secondary
    End point timeframe
    Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    55
    Units: months
        median (confidence interval 90%)
    2.3 (1.4 to 3.3)
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    Duration of Response is defined as the time from the first observation of CR or PR to the first observation of progressive disease (PD) or death from any cause. A response is defined as a confirmed objective status of CR or PR. For participants who are not known to have died as of the data inclusion cut-off date and who do not have PD, the duration will be censored at the date of the last objective progression free disease assessment prior to the date of any subsequent anticancer therapy. Analysis Population Description: All randomized participants who received at least 1 dose of drug with Best Overall Response of Complete Response or Partial Response.5 participants were censored.
    End point type
    Secondary
    End point timeframe
    First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    55 [2]
    Units: months
        median (confidence interval 90%)
    8.7 (7 to 99999)
    Notes
    [2] - 99999 = Upper limit is not estimable based on sample size.
    No statistical analyses for this end point

    Secondary: Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)

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    End point title
    		 Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)
    End point description
    The LCSS participants scale is a 9-item questionnaire. Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life. Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines. Scores range from 0 (for best outcome) to 100 (for worst outcome). The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS. Analysis Population Description: The LCSS evaluable population consisted of all enrolled participants who had a baseline LCSS measurement and at least 1 post-baseline measurement. The population was evaluated for changes in the ASBI (improved, stable, worsened), with improvement/worsening based on trends seen in sets of consecutive ASBI assessments with respect to baseline ASBI.
    End point type
    Secondary
    End point timeframe
    Baseline until End of Study (Up to 27.1 Months)
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    46
    Units: participants
    number (not applicable)
        Improved
    12
        Worsened
    6
        Stable
    18
        Unknown
    10
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618

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    End point title
    		 Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
    End point description
    Analysis Population Description : All randomized participants who received at least 1 dose of drug and had evaluable PK data
    End point type
    Secondary
    End point timeframe
    Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    48 [3]
    Units: nanogram per milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Day 2/Cycle 1 (n=41)
    3430 ( 50 )
        Day 2/Cycle 2 (n=48)
    3560 ( 40 )
    Notes
    [3] - The geometric coefficient of variation is a percentage.
    No statistical analyses for this end point

    Secondary: PK: Maximum Plasma Concentration (Cmax) of Pemetrexed

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    End point title
    		 PK: Maximum Plasma Concentration (Cmax) of Pemetrexed
    End point description
    Analysis Population Description : All randomized participants who received at least 1 dose of drug and evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    43 [4]
    Units: microgram per milliliter (μg/mL)
    geometric mean (geometric coefficient of variation)
        Day 1/Cycle 1 (n=40)
    102 ( 50 )
        Day 1/Cycle 2 (n=43)
    96.8 ( 42 )
    Notes
    [4] - The geometric coefficient of variation is a percentage.
    No statistical analyses for this end point

    Secondary: PK: Area Under the plasma concentration vs. time Curve from time zero to infinity [AUC(0-∞)] of Pemetrexed

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    End point title
    		 PK: Area Under the plasma concentration vs. time Curve from time zero to infinity [AUC(0-∞)] of Pemetrexed
    End point description
    Analysis Population Description : All randomized participants who received at least 1 dose of drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    43 [5]
    Units: microgram*hour per milliliter (µg*hr/mL)
    geometric mean (geometric coefficient of variation)
        Day 1/Cycle 1(n=40)
    193 ( 31 )
        Day 1/Cycle 2(n=43)
    202 ( 33 )
    Notes
    [5] - The geometric coefficient of variation is a percentage.
    No statistical analyses for this end point

    Secondary: PK: Area Under the plasma concentration vs. time Curve from time zero to infinity [AUC(0-∞)] of LY2603618

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    End point title
    		 PK: Area Under the plasma concentration vs. time Curve from time zero to infinity [AUC(0-∞)] of LY2603618
    End point description
    Analysis Population Description: All randomized participants who received at least 1 dose of drug and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
    End point values
    		 LY2603618 and Pemetrexed
    Number of subjects analysed
    48 [6]
    Units: nanograms*hour per milliliter (ng*h/mL)
    geometric mean (geometric coefficient of variation)
        Day 2/Cycle 1(n=41)
    38000 ( 85 )
        Day 2/Cycle 2(n=48)
    41500 ( 88 )
    Notes
    [6] - The geometric coefficient of variation is a percentage.
    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
    I2I-MC-JMMD
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    LY2603618-150mg/m2+PEMETREXED-500mg/m2
    Reporting group description
    		 -

    Serious adverse events
    		 LY2603618-150mg/m2+PEMETREXED-500mg/m2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 55 (29.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    pericardial effusion malignant
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    road traffic accident
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    spinal compression fracture
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    convulsion
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    thrombocytopenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    diarrhoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    gastritis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    haemoptysis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    dermatitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    pneumonia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    pseudomembranous colitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    sepsis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LY2603618-150mg/m2+PEMETREXED-500mg/m2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 55 (94.55%)
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 55 (12.73%)
         occurrences all number
    7
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    6 / 55 (10.91%)
         occurrences all number
    6
    Vascular disorders
    flushing
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    5
    headache
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    5
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    10 / 55 (18.18%)
         occurrences all number
    12
    leukopenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    8 / 55 (14.55%)
         occurrences all number
    13
    neutropenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    15 / 55 (27.27%)
         occurrences all number
    35
    thrombocytopenia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    6
    General disorders and administration site conditions
    face oedema
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    4
    fatigue
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    20 / 55 (36.36%)
         occurrences all number
    27
    pyrexia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    5
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    6 / 55 (10.91%)
         occurrences all number
    6
    constipation
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    11 / 55 (20.00%)
         occurrences all number
    15
    diarrhoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 55 (12.73%)
         occurrences all number
    7
    dyspepsia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    nausea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    18 / 55 (32.73%)
         occurrences all number
    28
    stomatitis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    5
    vomiting
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    12 / 55 (21.82%)
         occurrences all number
    12
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 55 (12.73%)
         occurrences all number
    8
    dyspnoea
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    7 / 55 (12.73%)
         occurrences all number
    7
    haemoptysis
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    nasal congestion
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    4
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    6
    myalgia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Infections and infestations
    herpes zoster
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    9 / 55 (16.36%)
         occurrences all number
    9
    dehydration
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    hypokalaemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    4
    hyponatraemia
    alternative dictionary used: MedDRA 14.1
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    4

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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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    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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