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    Clinical Trial Results:
    A Randomized Phase 2 Placebo-Controlled Study of LY2495655 in Patients with Advanced or Metastatic Pancreatic Cancer Receiving Chemotherapy

    Summary
    EudraCT number
    		 2011-003822-29
    Trial protocol
    		 BE   GB   NO  
    Global end of trial date
    28 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jan 2020
    First version publication date
    05 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I1Q-MC-JDDG
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01505530
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 12552
    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
    28 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.
    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
    13 Dec 2011
    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
    Canada: 5
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    United States: 27
    Country: Number of subjects enrolled
    Israel: 57
    Country: Number of subjects enrolled
    Norway: 5
    Worldwide total number of subjects
    125
    EEA total number of subjects
    36
    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)
    48
    From 65 to 84 years
    77
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 The reasons for discontinuation listed in the participant flow are the reasons the participant discontinued treatment and a participant was considered to have “completed” the trial if they died due to any cause while on study or completed treatment and was known to be alive at the last scheduled follow-up.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 300 mg LY2495655 + chemotherapy
    Arm description
    		 300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2495655
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

    Investigational medicinal product name
    Standard of Care Chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).

    Arm title
    		 100 mg LY2495655 + chemotherapy
    Arm description
    		 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).
    Arm type
    		 Experimental

    Investigational medicinal product name
    LY2495655
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

    Investigational medicinal product name
    Standard of Care Chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).

    Arm title
    		 Placebo + chemotherapy
    Arm description
    		 Placebo in combination with standard of care chemotherapy (investigator's choice).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.

    Investigational medicinal product name
    Standard of Care Chemotherapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).

    Number of subjects in period 1
    		300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Started
    41
    43
    41
    Received At Least One Dose of Study Drug
    41
    42
    41
    Completed One Cycle of Study Drug
    29
    27
    31
    Completed
    0
    0
    0
    Not completed
    41
    43
    41
         Adverse event, serious fatal
    7
    6
    5
         Consent withdrawn by subject
    7
    8
    6
         Physician decision
    6
    2
    5
         entry criteria not met
    -
    1
    -
         Adverse event, non-fatal
    1
    1
    -
         Progressive Disease
    19
    17
    18
         Sponsor Decision
    1
    8
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    300 mg LY2495655 + chemotherapy
    Reporting group description
    		 300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).

    Reporting group title
    100 mg LY2495655 + chemotherapy
    Reporting group description
    		 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).

    Reporting group title
    Placebo + chemotherapy
    Reporting group description
    		 Placebo in combination with standard of care chemotherapy (investigator's choice).

    Reporting group values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy Total
    Number of subjects
    		 41 43 41 125
    Age categorical
    Units: Subjects
        Adults (18-64 years old)
    		 0
        Adults (65-84 years old)
    		 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65.0 ± 11.3 67.4 ± 10.7 68.4 ± 9.1 -
    Gender, Male/Female
    Units:
        Female
    		 16 13 15 44
        Male
    		 25 30 26 81
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 3 0 3
        Not Hispanic or Latino
    		 20 19 27 66
        Unknown or Not Reported
    		 21 21 14 56
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 0 0 1 1
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0
        Black or African American
    		 3 1 5 9
        White
    		 38 42 35 115
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    300 mg LY2495655 + chemotherapy
    Reporting group description
    		 300 milligram (mg) LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).

    Reporting group title
    100 mg LY2495655 + chemotherapy
    Reporting group description
    		 100 mg LY2495655 intravenous (IV) in combination with standard of care chemotherapy (investigator's choice).

    Reporting group title
    Placebo + chemotherapy
    Reporting group description
    		 Placebo in combination with standard of care chemotherapy (investigator's choice).

    Primary: Overall survival (OS)

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    End point title
    		 Overall survival (OS)
    End point description
    Overall survival (OS) duration was measured from the date of randomization to the date of death from any cause. Participants who were alive at data cut-off for the OS analysis or lost to follow-up were censored on the last date the participant was known to be alive. Censored participants; 300 mg LY2495655 = 9,100 mg LY2495655 =13, Placebo= 16.
    End point type
    Primary
    End point timeframe
    Baseline to Death from Any Cause (Up to 23 months)
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [1]
    43 [2]
    41 [3]
    Units: months
        median (confidence interval 90%)
    8.02 (5.95 to 10.02)
    9.82 (5.85 to 13.54)
    10.45 (8.38 to 14.49)
    Notes
    [1] - All randomized participants.
    [2] - All randomized participants.
    [3] - All randomized participants.
    Statistical analysis title
    		 Statistical Analysis of Primary Endpoint
    Statistical analysis description
    Hazard ratio and 90% CI are obtained from an unstratified Cox model adjusted for the following covariates: first line therapy, weight loss prior to study entry, disease stage at study entry, and Eastern Cooperative Oncology Group (ECOG) performance status at study entry.
    Comparison groups
    300 mg LY2495655 + chemotherapy v Placebo + chemotherapy
    Number of subjects included in analysis
    82
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 2.65
    Statistical analysis title
    		 Statistical Analysis of Primary Endpoint
    Statistical analysis description
    Hazard ratio and 90% CI are obtained from an unstratified Cox model adjusted for the following covariates: first line therapy, weight loss prior to study entry, disease stage at study entry, and ECOG performance status at study entry.
    Comparison groups
    100 mg LY2495655 + chemotherapy v Placebo + chemotherapy
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 2.05

    Secondary: Progression free survival (PFS)

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    End point title
    		 Progression free survival (PFS)
    End point description
    PFS was defined as the time from date of first dose to the first observation of disease progression or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.1) criteria. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.
    End point type
    Secondary
    End point timeframe
    Baseline to Disease Progression or Death from Any Cause (Up to 16 months)
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [4]
    43 [5]
    41 [6]
    Units: months
        median (confidence interval 90%)
    4.90 (3.32 to 6.01)
    6.87 (5.36 to 7.89)
    8.21 (4.99 to 9.36)
    Notes
    [4] - All randomized participants.
    [5] - All randomized participants.
    [6] - All randomized participants.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Tumor Response Rate (RR)

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    End point title
    		 Percentage of Participants with Tumor Response Rate (RR)
    End point description
    Response rate (RR) was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; Stable Disease (SD) was defined as small changes that did not meet above criteria.
    End point type
    Secondary
    End point timeframe
    Baseline to Disease Progression (Up to 11 months)
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [7]
    43 [8]
    41 [9]
    Units: percentage of participants
        number (not applicable)
    22
    25.6
    26.8
    Notes
    [7] - All randomized participants.
    [8] - All randomized participants.
    [9] - All randomized participants.
    No statistical analyses for this end point

    Secondary: Duration of Response

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    End point title
    		 Duration of Response
    End point description
    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 millimeters (mm). Partial Response (PR) was defined as having at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.
    End point type
    Secondary
    End point timeframe
    First CR or PR to Disease Progression (Up to 11 months)
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [10]
    43 [11]
    41 [12]
    Units: months
        median (confidence interval 90%)
    5.86 (3.91 to 5.98)
    8.02 (3.09 to 9.63)
    9.20 (9.03 to 10.45)
    Notes
    [10] - All randomized participants.
    [11] - All randomized participants.
    [12] - All randomized participants.
    No statistical analyses for this end point

    Secondary: Change in Lean Body Mass

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    End point title
    		 Change in Lean Body Mass
    End point description
    Change in lean body mass was assessed using dual-energy x-ray absorptiometry (DXA).
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 3, 5, 7, 9 and 11; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [13]
    42 [14]
    41 [15]
    Units: grams (g)
    arithmetic mean (standard deviation)
        Baseline
    43742.92 ± 10460.69
    44307.12 ± 9853.15
    42870.99 ± 8971.73
        Cycle 3
    42629.79 ± 10263.53
    44250.67 ± 11600.33
    42282.45 ± 8523.35
        Cycle 5
    43121.85 ± 11249.28
    45697.82 ± 12035.96
    43041.45 ± 7649.44
        Cycle 7
    44407.02 ± 11685.15
    45486.34 ± 11424.00
    45997.59 ± 9429.50
        Cycle 9
    46879.22 ± 12316.64
    43656.49 ± 12335.08
    43405.26 ± 7217.48
        Cycle 11
    46155.53 ± 9984.09
    433316.42 ± 11436.93
    45667.63 ± 8100.86
    Notes
    [13] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [14] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [15] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    No statistical analyses for this end point

    Secondary: Change in Physical Performance Measures Using Hand Grip Strength

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    End point title
    		 Change in Physical Performance Measures Using Hand Grip Strength
    End point description
    Hand grip strength (HGS) of the non-dominant hand measured using a hand dynamometer.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [16]
    42 [17]
    41 [18]
    Units: kilogram (kg)
    arithmetic mean (standard deviation)
        Baseline
    28.59 ± 11.99
    29.00 ± 11.35
    27.46 ± 12.54
        Cycle 2
    25.90 ± 13.49
    26.70 ± 12.27
    25.26 ± 11.80
        Cycle 4
    25.56 ± 13.67
    24.47 ± 10.46
    28.02 ± 13.10
        Cycle 6
    26.58 ± 9.65
    26.32 ± 14.33
    27.43 ± 14.01
        Cycle 8
    27.89 ± 11.46
    26.22 ± 14.92
    25.44 ± 12.05
        Cycle 10
    25.13 ± 13.15
    29.23 ± 14.81
    33.27 ± 14.25
    Notes
    [16] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [17] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [18] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    No statistical analyses for this end point

    Secondary: Change in Physical Performance Measures Using the Time Up and Go (TUG) Test

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    End point title
    		 Change in Physical Performance Measures Using the Time Up and Go (TUG) Test
    End point description
    Time Up and Go (TUG) is a timed walking test designed to measure gait performance and balance. It measures in seconds the time taken by an individual to stand up from a standard arm chair (approximate seat height of 46 cm [18in], arm height 65 cm [25.6 in]), walk a distance of 3 meters (118 inches, approximately 10 feet), turn, walk back to the chair, and sit down.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [19]
    42 [20]
    41 [21]
    Units: seconds
    arithmetic mean (standard deviation)
        Baseline
    10.70 ± 5.06
    10.16 ± 4.53
    10.04 ± 4.04
        Cycle 2
    9.19 ± 2.60
    10.15 ± 3.93
    10.64 ± 4.46
        Cycle 4
    9.33 ± 3.23
    12.19 ± 8.96
    9.18 ± 2.60
        Cycle 6
    10.14 ± 2.02
    8.84 ± 2.94
    9.77 ± 3.96
        Cycle 8
    9.28 ± 2.51
    7.26 ± 2.13
    9.03 ± 4.30
        Cycle 10
    10.56 ± 1.40
    7.75 ± 2.38
    9.76 ± 5.75
    Notes
    [19] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [20] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [21] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    No statistical analyses for this end point

    Secondary: Change in physical performance measures using the 6 minute walk test

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    End point title
    		 Change in physical performance measures using the 6 minute walk test
    End point description
    The 6 minute walk test measured the distance walked in 6 minutes, as quickly as possible, without running.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [22]
    42 [23]
    41 [24]
    Units: meter
    arithmetic mean (standard deviation)
        Baseline
    351.49 ± 115.18
    382.49 ± 131.41
    381.62 ± 94.68
        Cycle 2
    368.08 ± 137.65
    361.53 ± 143.70
    376.31 ± 107.25
        Cycle 4
    379.90 ± 208.66
    323.79 ± 140.26
    386.48 ± 126.56
        Cycle 6
    354.20 ± 104.74
    416.30 ± 102.49
    376.45 ± 132.05
        Cycle 8
    365.00 ± 75.71
    347.32 ± 203.49
    392.13 ± 113.43
        Cycle 10
    308.19 ± 57.23
    372.15 ± 172.40
    391.41 ± 143.18
    Notes
    [22] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [23] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [24] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    No statistical analyses for this end point

    Secondary: Change in physical performance measures using stair climbing time (StC)

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    End point title
    		 Change in physical performance measures using stair climbing time (StC)
    End point description
    Stair climbing time (StC) measured the ascend and descend of a flight of 12 steps (each step 18 cm high and 28 cm deep).
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 3, 5, 7, 9 and 11; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [25]
    42 [26]
    41 [27]
    Units: joule/second
    arithmetic mean (standard deviation)
        Baseline
    211.25 ± 129.57
    206.92 ± 110.52
    178.25 ± 65.18
        Cycle 3
    203.24 ± 113.76
    203.70 ± 87.82
    170.49 ± 76.52
        Cycle 5
    230.23 ± 135.31
    211.99 ± 93.00
    186.55 ± 95.20
        Cycle 7
    198.24 ± 83.19
    235.82 ± 111.95
    200.79 ± 130.74
        Cycle 9
    217.82 ± 131.34
    197.49 ± 102.51
    160.59 ± 87.60
        Cycle 11
    193.24 ± 96.70
    221.59 ± 107.49
    188.78 ± 188.78
    Notes
    [25] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [26] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    [27] - All participants that received at least one dose of study drug and had evaluable post-baseline data.
    No statistical analyses for this end point

    Secondary: Change in Patient Reported Outcomes (PRO)

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    End point title
    		 Change in Patient Reported Outcomes (PRO)
    End point description
    Data from PRO scales are not be presented. An error in coding the scales (coded differently early and late in the study) occurred. Unable to determine which results were affected therefore analysis not completed.
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    0 [28]
    0 [29]
    0 [30]
    Units: units on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    Notes
    [28] - Writer To Revise
    [29] - Writer To Revise
    [30] - Writer To Revise
    No statistical analyses for this end point

    Secondary: Change in Pain Scale Physical Functioning

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    End point title
    		 Change in Pain Scale Physical Functioning
    End point description
    The 36-item Short-Form Health Survey (SF-36) pain scale is a generic, health-related scale assessing participant’s quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). The PCS physical functioning domain score ranges from 0 to 100 (higher scores indicate better health status).
    End point type
    Secondary
    End point timeframe
    Baseline, Cycles 2, 4, 6, 8 and 10; Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [31]
    43 [32]
    41 [33]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Baseline
    6.62 ± 2.23
    6.81 ± 2.55
    5.89 ± 2.54
        Cycle 2
    4.48 ± 2.09
    5.63 ± 2.81
    5.04 ± 2.03
        Cycle 4
    5.33 ± 1.91
    4.78 ± 2.02
    4.83 ± 2.50
        Cycle 6
    4.38 ± 1.51
    4.65 ± 2.29
    4.25 ± 1.91
        Cycle 8
    4.14 ± 1.46
    5.85 ± 2.44
    5.00 ± 2.26
        Cycle 10
    4.57 ± 2.57
    5.58 ± 2.87
    3.55 ± 1.92
    Notes
    [31] - All randomized participants with evaluable SF-36 domain scores.
    [32] - All randomized participants with evaluable SF-36 domain scores.
    [33] - All randomized participants with evaluable SF-36 domain scores.
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-LY2495655 Antibodies

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    End point title
    		 Number of Participants With Anti-LY2495655 Antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1
    End point values
    		 300 mg LY2495655 + chemotherapy 100 mg LY2495655 + chemotherapy Placebo + chemotherapy
    Number of subjects analysed
    41 [34]
    43 [35]
    41 [36]
    Units: participants
    0
    1
    1
    Notes
    [34] - All randomized participants.
    [35] - All randomized participants.
    [36] - All randomized participants.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 16 months
    Adverse event reporting additional description
    I1Q-MC-JDDG
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    300 mg LY2495655
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    100 mg LY2495655
    Reporting group description
    		 -

    Serious adverse events
    		 300 mg LY2495655 Placebo 100 mg LY2495655
    Total subjects affected by serious adverse events
         subjects affected / exposed
    26 / 41 (63.41%)
    25 / 41 (60.98%)
    30 / 42 (71.43%)
         number of deaths (all causes)
    3
    2
    5
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    malignant pleural effusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    tumour haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    tumour pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypotension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    phlebitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    general physical health deterioration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    oedema peripheral
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    5 / 41 (12.20%)
    7 / 42 (16.67%)
         occurrences causally related to treatment / all
    2 / 8
    5 / 8
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    hypersensitivity
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    ovarian cyst
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [1]
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute respiratory failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dyspnoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary congestion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    confusional state
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    device occlusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood bilirubin increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    blood creatinine increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    myocardial infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cerebral ischaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cerebrovascular accident
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    syncope
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neutropenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    splenic infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    splenic vein thrombosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    0 / 41 (0.00%)
    4 / 42 (9.52%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 41 (4.88%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    duodenal obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    duodenal perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    dysphagia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    haematemesis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    impaired gastric emptying
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    intra-abdominal haematoma
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    intra-abdominal haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    large intestinal obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    obstruction gastric
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pancreatitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    4 / 42 (9.52%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    bile duct obstruction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cholangitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    4 / 41 (9.76%)
    3 / 42 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    2 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cholecystitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hepatic failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hyperbilirubinaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hydronephrosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    renal failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Endocrine disorders
    inappropriate antidiuretic hormone secretion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    back pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    bacteraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 41 (4.88%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    biliary sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    biliary tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    bronchitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    clostridium difficile infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    enterobacter infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    infusion site cellulitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 41 (0.00%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    liver abscess
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    neutropenic sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    pneumonia streptococcal
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    urosepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    viral labyrinthitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    dehydration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypercalcaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hyperglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hypoglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    hyponatraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    0 / 42 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    ketoacidosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Event is gender specific
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 300 mg LY2495655 Placebo 100 mg LY2495655
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 41 (100.00%)
    41 / 41 (100.00%)
    41 / 42 (97.62%)
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
    2 / 42 (4.76%)
         occurrences all number
    5
    8
    18
    hot flush
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    2 / 42 (4.76%)
         occurrences all number
    14
    5
    6
    hypertension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 41 (7.32%)
    4 / 42 (9.52%)
         occurrences all number
    1
    8
    22
    hypotension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    5 / 42 (11.90%)
         occurrences all number
    13
    2
    9
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
    2 / 42 (4.76%)
         occurrences all number
    10
    13
    5
    chest pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    2 / 42 (4.76%)
         occurrences all number
    18
    3
    19
    fatigue
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    25 / 41 (60.98%)
    29 / 41 (70.73%)
    28 / 42 (66.67%)
         occurrences all number
    132
    185
    148
    influenza like illness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 41 (12.20%)
    4 / 41 (9.76%)
    4 / 42 (9.52%)
         occurrences all number
    16
    6
    5
    mucosal inflammation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 41 (17.07%)
    4 / 41 (9.76%)
    6 / 42 (14.29%)
         occurrences all number
    26
    14
    11
    oedema peripheral
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    9 / 41 (21.95%)
    16 / 41 (39.02%)
    14 / 42 (33.33%)
         occurrences all number
    46
    55
    40
    pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 41 (12.20%)
    3 / 41 (7.32%)
    5 / 42 (11.90%)
         occurrences all number
    10
    7
    36
    peripheral swelling
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    3 / 42 (7.14%)
         occurrences all number
    16
    7
    6
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    13 / 41 (31.71%)
    13 / 41 (31.71%)
    11 / 42 (26.19%)
         occurrences all number
    24
    25
    41
    Immune system disorders
    hypersensitivity
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences all number
    4
    1
    2
    Reproductive system and breast disorders
    vulvovaginal pruritus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed [2]
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 13 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 41 (17.07%)
    6 / 41 (14.63%)
    7 / 42 (16.67%)
         occurrences all number
    26
    21
    19
    dysphonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
    1 / 42 (2.38%)
         occurrences all number
    14
    16
    1
    dyspnoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    14 / 41 (34.15%)
    8 / 41 (19.51%)
    10 / 42 (23.81%)
         occurrences all number
    38
    32
    47
    epistaxis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    5 / 41 (12.20%)
    2 / 42 (4.76%)
         occurrences all number
    15
    13
    5
    hiccups
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 41 (7.32%)
    3 / 42 (7.14%)
         occurrences all number
    8
    4
    10
    oropharyngeal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences all number
    3
    1
    8
    pulmonary embolism
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    3 / 42 (7.14%)
         occurrences all number
    3
    9
    19
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    4 / 42 (9.52%)
         occurrences all number
    12
    12
    31
    confusional state
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    1 / 41 (2.44%)
    1 / 42 (2.38%)
         occurrences all number
    6
    1
    3
    depression
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    4 / 41 (9.76%)
    5 / 42 (11.90%)
         occurrences all number
    9
    21
    33
    insomnia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    1 / 41 (2.44%)
    4 / 42 (9.52%)
         occurrences all number
    39
    16
    21
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    3 / 42 (7.14%)
         occurrences all number
    0
    15
    18
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    4 / 41 (9.76%)
    3 / 42 (7.14%)
         occurrences all number
    0
    17
    18
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    3 / 41 (7.32%)
    3 / 42 (7.14%)
         occurrences all number
    8
    16
    16
    blood bilirubin increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    4 / 42 (9.52%)
         occurrences all number
    6
    6
    7
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    0 / 42 (0.00%)
         occurrences all number
    0
    16
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    5 / 41 (12.20%)
    4 / 42 (9.52%)
         occurrences all number
    14
    12
    7
    platelet count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 41 (19.51%)
    4 / 41 (9.76%)
    6 / 42 (14.29%)
         occurrences all number
    14
    11
    18
    weight decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    9 / 41 (21.95%)
    9 / 41 (21.95%)
    6 / 42 (14.29%)
         occurrences all number
    25
    49
    17
    white blood cell count decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    2 / 41 (4.88%)
    3 / 42 (7.14%)
         occurrences all number
    2
    2
    16
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    4 / 41 (9.76%)
    8 / 42 (19.05%)
         occurrences all number
    27
    21
    36
    dysgeusia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    7 / 41 (17.07%)
    4 / 42 (9.52%)
         occurrences all number
    23
    49
    11
    headache
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    2 / 41 (4.88%)
    3 / 42 (7.14%)
         occurrences all number
    22
    3
    16
    neuropathy peripheral
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    6 / 41 (14.63%)
    2 / 42 (4.76%)
         occurrences all number
    29
    20
    21
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 41 (12.20%)
    2 / 42 (4.76%)
         occurrences all number
    17
    66
    21
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 41 (29.27%)
    19 / 41 (46.34%)
    14 / 42 (33.33%)
         occurrences all number
    58
    68
    67
    neutropenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 41 (29.27%)
    13 / 41 (31.71%)
    9 / 42 (21.43%)
         occurrences all number
    35
    66
    50
    thrombocytopenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    9 / 41 (21.95%)
    14 / 41 (34.15%)
    11 / 42 (26.19%)
         occurrences all number
    28
    49
    37
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    4 / 41 (9.76%)
    2 / 42 (4.76%)
         occurrences all number
    0
    14
    10
    abdominal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 41 (29.27%)
    11 / 41 (26.83%)
    6 / 42 (14.29%)
         occurrences all number
    38
    50
    26
    ascites
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    7 / 41 (17.07%)
    4 / 42 (9.52%)
         occurrences all number
    8
    22
    12
    constipation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    12 / 41 (29.27%)
    9 / 41 (21.95%)
    15 / 42 (35.71%)
         occurrences all number
    40
    58
    61
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    22 / 41 (53.66%)
    20 / 41 (48.78%)
    17 / 42 (40.48%)
         occurrences all number
    51
    77
    82
    dry mouth
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    6 / 41 (14.63%)
    4 / 42 (9.52%)
         occurrences all number
    20
    16
    22
    dyspepsia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    4 / 41 (9.76%)
    3 / 42 (7.14%)
         occurrences all number
    15
    14
    8
    flatulence
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    4 / 41 (9.76%)
    2 / 42 (4.76%)
         occurrences all number
    20
    12
    21
    mouth ulceration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    2 / 41 (4.88%)
    2 / 42 (4.76%)
         occurrences all number
    12
    2
    13
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    18 / 41 (43.90%)
    19 / 41 (46.34%)
    19 / 42 (45.24%)
         occurrences all number
    54
    75
    119
    stomatitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 41 (12.20%)
    4 / 41 (9.76%)
    4 / 42 (9.52%)
         occurrences all number
    20
    16
    9
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    13 / 41 (31.71%)
    14 / 41 (34.15%)
    15 / 42 (35.71%)
         occurrences all number
    24
    35
    41
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 41 (14.63%)
    3 / 41 (7.32%)
    6 / 42 (14.29%)
         occurrences all number
    23
    38
    49
    dermatitis acneiform
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    3 / 41 (7.32%)
    2 / 42 (4.76%)
         occurrences all number
    6
    7
    3
    dry skin
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 41 (9.76%)
    4 / 41 (9.76%)
    4 / 42 (9.52%)
         occurrences all number
    17
    24
    34
    pruritus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 41 (12.20%)
    2 / 41 (4.88%)
    3 / 42 (7.14%)
         occurrences all number
    13
    9
    11
    rash
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 41 (17.07%)
    6 / 41 (14.63%)
    6 / 42 (14.29%)
         occurrences all number
    24
    34
    13
    rash maculo-papular
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    4 / 41 (9.76%)
    2 / 42 (4.76%)
         occurrences all number
    4
    12
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    3 / 42 (7.14%)
         occurrences all number
    18
    17
    17
    back pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 41 (19.51%)
    4 / 41 (9.76%)
    8 / 42 (19.05%)
         occurrences all number
    25
    11
    43
    bone pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    0
    4
    joint swelling
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    2 / 42 (4.76%)
         occurrences all number
    12
    12
    9
    muscle spasms
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    1 / 42 (2.38%)
         occurrences all number
    23
    17
    2
    musculoskeletal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    3 / 41 (7.32%)
    1 / 42 (2.38%)
         occurrences all number
    24
    12
    2
    myalgia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 41 (12.20%)
    4 / 42 (9.52%)
         occurrences all number
    10
    25
    19
    pain in extremity
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 41 (19.51%)
    3 / 41 (7.32%)
    1 / 42 (2.38%)
         occurrences all number
    27
    26
    1
    Infections and infestations
    device related infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    0 / 42 (0.00%)
         occurrences all number
    0
    6
    0
    oral candidiasis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 41 (4.88%)
    4 / 41 (9.76%)
    1 / 42 (2.38%)
         occurrences all number
    2
    14
    2
    tooth infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 41 (0.00%)
    3 / 42 (7.14%)
         occurrences all number
    0
    0
    6
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    3 / 41 (7.32%)
    0 / 42 (0.00%)
         occurrences all number
    0
    6
    0
    urinary tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 41 (2.44%)
    5 / 41 (12.20%)
    6 / 42 (14.29%)
         occurrences all number
    1
    9
    10
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    18 / 41 (43.90%)
    21 / 41 (51.22%)
    17 / 42 (40.48%)
         occurrences all number
    60
    114
    84
    dehydration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    5 / 41 (12.20%)
    6 / 41 (14.63%)
    3 / 42 (7.14%)
         occurrences all number
    7
    11
    5
    hyperglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    7 / 41 (17.07%)
    3 / 41 (7.32%)
    1 / 42 (2.38%)
         occurrences all number
    15
    25
    3
    hypoalbuminaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    5 / 41 (12.20%)
    3 / 42 (7.14%)
         occurrences all number
    8
    13
    5
    hypoglycaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 41 (2.44%)
    3 / 42 (7.14%)
         occurrences all number
    0
    1
    4
    hypokalaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    8 / 41 (19.51%)
    3 / 42 (7.14%)
         occurrences all number
    11
    19
    9
    hypomagnesaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 41 (7.32%)
    2 / 41 (4.88%)
    5 / 42 (11.90%)
         occurrences all number
    15
    11
    13
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Event is gender specific

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2012
    Protocol amendment (b) The study schedule was revised to clarify that cycles should align with study therapy (LY2495655 or placebo) dosing and how data should be captured and assessments performed in order to ensure that data will be captured in a non-discrepant manner. Also, in the study schedule changes the cycle length and requirements for entering the post-discontinuation follow-up period was clarified. In addition, references to the post-first-line therapy days was removed and not determined by the chemotherapy regimen. Added expectation for participants who are discontinued from study therapy to be followed and assessed for primary secondary endpoints. Other clarifying texts regarding the standard of care determination, details regarding assessments, observation period, sourcing of chemotherapy agents, direction when unblinding study therapy, instructions on laboratory testing, and the replacement participants prior to cycle 1.

    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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