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    Clinical Trial Results:
    Randomized Phase 2 Trial Evaluating Pharmacokinetics and Safety of Four Ramucirumab Dosing Regimens in Second-Line Gastric or Gastroesophageal Junction Adenocarcinoma

    Summary
    EudraCT number
    		 2014-003791-23
    Trial protocol
    		 HU   SK   FR   PL   RO  
    Global end of trial date
    05 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jun 2020
    First version publication date
    17 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    I4T-MC-JVDB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02443883
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 15608
    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
    05 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to evaluate the safety and pharmacokinetics of administering various dose regimens of ramucirumab in participants with advanced gastric cancer whose disease has progressed during or following prior 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 countries in which a study was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Romania: 27
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Poland: 24
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    Slovakia: 7
    Country: Number of subjects enrolled
    Australia: 8
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Russian Federation: 15
    Country: Number of subjects enrolled
    New Zealand: 7
    Country: Number of subjects enrolled
    Argentina: 14
    Worldwide total number of subjects
    164
    EEA total number of subjects
    101
    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)
    111
    From 65 to 84 years
    52
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study completion was defined as death due to any cause or disease progression.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ramucirumab Regimen 1
    Arm description
    		 Ramucirumab (8milligram per kilogram [mg/kg]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    8 mg/kg Ramucirumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ramucirumab (8milligram per kilogram [mg/kg]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Arm title
    		 Ramucirumab Regimen 2
    Arm description
    		 Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    12 mg/kg Ramucirumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Arm title
    		 Ramucirumab Regimen 3
    Arm description
    		 Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    6 mg/kg Ramucirumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.

    Arm title
    		 Ramucirumab Regimen 4
    Arm description
    		 Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.
    Arm type
    		 Experimental

    Investigational medicinal product name
    8 mg/kg Ramucirumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.

    Number of subjects in period 1
    		Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4
    Started
    40
    42
    41
    41
    Received at least one dose of study drug
    38
    42
    41
    40
    Completed
    34
    38
    40
    36
    Not completed
    6
    4
    1
    5
         Consent withdrawn by subject
    1
    -
    -
    2
         Physician decision
    1
    1
    -
    3
         Adverse event, non-fatal
    -
    1
    -
    -
         Lost to follow-up
    3
    2
    1
    -
         Randomized, but never treated
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ramucirumab Regimen 1
    Reporting group description
    		 Ramucirumab (8milligram per kilogram [mg/kg]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 2
    Reporting group description
    		 Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 3
    Reporting group description
    		 Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 4
    Reporting group description
    		 Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.

    Reporting group values
    		 Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4 Total
    Number of subjects
    		 40 42 41 41 164
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.5 ± 14.0 58.7 ± 10.4 60.5 ± 12.3 56.2 ± 12.9 -
    Gender categorical
    Units: Subjects
        Female
    		 11 10 6 9 36
        Male
    		 29 32 35 32 128
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 6 3 6 7 22
        Not Hispanic or Latino
    		 32 37 33 32 134
        Unknown or Not Reported
    		 2 2 2 2 8
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 1 0 0 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 0 0 0 0 0
        White
    		 32 35 35 33 135
        More than one race
    		 6 7 5 6 24
        Unknown or Not Reported
    		 1 0 1 1 3
    Region of Enrollment
    Units: Subjects
        New Zealand
    		 2 1 1 3 7
        Argentina
    		 5 1 2 6 14
        Romania
    		 4 6 10 7 27
        Turkey
    		 3 4 2 2 11
        Hungary
    		 0 3 3 1 7
        United States
    		 2 3 2 1 8
        Poland
    		 6 6 7 5 24
        United Kingdom
    		 7 10 8 6 31
        Slovakia
    		 3 1 2 1 7
        Australia
    		 1 2 0 5 8
        France
    		 1 1 2 1 5
        Russia
    		 6 4 2 3 15

    End points

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    End points reporting groups
    Reporting group title
    Ramucirumab Regimen 1
    Reporting group description
    		 Ramucirumab (8milligram per kilogram [mg/kg]) given intravenously (IV) on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 2
    Reporting group description
    		 Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 3
    Reporting group description
    		 Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 4
    Reporting group description
    		 Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.

    Primary: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab

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    End point title
    		 Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab [1]
    End point description
    The Cmin is the minimum observed serum concentration of ramucirumab. Analysis population description (APD) included all randomized participants who received at least one dose of ramucirumab and had evaluable ramucirumab PK data.
    End point type
    Primary
    End point timeframe
    Day 29, 43, 71 and 85: predose
    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: No inferential statistics were planned or conducted for this endpoint.
    End point values
    		 Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4
    Number of subjects analysed
    38 [2]
    42 [3]
    41 [4]
    40 [5]
    Units: microgram per milliliter (µg/mL)
    geometric mean (geometric coefficient of variation)
        Day 29
    32.9 ± 51
    59.5 ± 60
    69.3 ± 45
    71.6 ± 37
        Day 43
    47.6 ± 36
    71.0 ± 58
    83.0 ± 57
    57.4 ± 44
        Day 71
    60.4 ± 34
    65.0 ± 60
    122 ± 65
    97.1 ± 46
        Day 85
    64.3 ± 40
    79.4 ± 46
    125 ± 56
    81.6 ± 50
    Notes
    [2] - Day 29:n =29, Day 43:n = 15, Day 71:n = 6, Day 85: n = 6
    [3] - Day 29:n =32, Day 43:n = 22, Day 71:n = 12, Day 85: n = 10
    [4] - Day 29:n =28, Day 43:n = 18, Day 71:n = 12, Day 85: n = 11
    [5] - Day 29:n =31, Day 43:n = 17, Day 71:n = 10, Day 85: n = 9
    No statistical analyses for this end point

    Secondary: Immunogenicity: Number of Participants with Anti-Ramucirumab Antibodies

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    End point title
    		 Immunogenicity: Number of Participants with Anti-Ramucirumab Antibodies
    End point description
    Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group. A treatment-emergent anti-drug antibodies (TEADA) sample was defined as: a post treatment sample with at least a 4-fold increase in titer from pre treatment sample; or 1:20 post treatment titer for participants that had no detectable ADA titer at baseline. APD included all randomized participants who received at least 1 dose of ramucirumab and had evaluable anti-ramucirumab antibody measurement.
    End point type
    Secondary
    End point timeframe
    Predose Cycle 1 Through Short Term Follow Up (Up to 5 Months)
    End point values
    		 Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4
    Number of subjects analysed
    19
    26
    20
    22
    Units: Participants
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Rate of Progression Free Survival (PFS) at the First 6-Week Tumor Assessment

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    End point title
    		 Rate of Progression Free Survival (PFS) at the First 6-Week Tumor Assessment
    End point description
    PFS defined as the time from first day of therapy to first evidence of disease progression per RECIST v1.1 or death from any cause up to the first 6-week tumor assessment. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions,taking as reference smallest sum on study and absolute increase of at least 5 mm.Appearance of 1 or more new lesions was also considered progression. Nontarget PD is unequivocal progression of existing nontarget lesions.Appearance of 1 or more new nontarget lesions was also considered PD.Participants with no baseline disease assessment: PFS time was censored at the randomization date,regardless of whether or not objectively determined disease progression or death has been observed.APD included randomized participants. Censored participants:Ramucirumab Regimen 1=8,Ramucirumab Regimen 2=10,Ramucirumab Regimen 3=8 and Ramucirumab Regimen 4=12. PFS rate at the first 6- week assessments was estimated using the Kaplan-Meir method.
    End point type
    Secondary
    End point timeframe
    Baseline until the first 6-week tumor assessment
    End point values
    		 Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4
    Number of subjects analysed
    40
    42
    41
    41
    Units: Months
        median (confidence interval 95%)
    43.9 (27.3 to 59.3)
    61.9 (44.9 to 75.0)
    53.0 (36.2 to 67.3)
    51.2 (34.2 to 65.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 4 Years
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Ramucirumab Regimen 1
    Reporting group description
    		 Ramucirumab (8 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 2
    Reporting group description
    		 Ramucirumab (12 mg/kg) given IV on day 1 and day 15 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 3
    Reporting group description
    		 Ramucirumab (6 mg/kg) given IV on day 1, 8, 15 and 22 of each cycle (28-day cycle) until discontinuation criteria are met.

    Reporting group title
    Ramucirumab Regimen 4
    Reporting group description
    		 Ramucirumab (8 mg/kg) given IV on day 1 and day 8 of each cycle (21-day cycle) until discontinuation criteria are met.

    Serious adverse events
    		 Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 38 (26.32%)
    11 / 42 (26.19%)
    10 / 41 (24.39%)
    18 / 40 (45.00%)
         number of deaths (all causes)
    1
    2
    7
    3
         number of deaths resulting from adverse events
    0
    1
    5
    0
    Surgical and medical procedures
    thoracic cavity drainage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chest pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    fatigue
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sudden death
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    dyspnoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemoptysis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumothorax
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    respiratory failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    Investigations
    blood creatinine increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    overdose
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    procedural nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    procedural vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    cardiac arrest
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    cardiac failure congestive
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    syncope
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    abdominal pain upper
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ascites
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    constipation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    duodenal ulcer haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    dysphagia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastric haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    3 / 41 (7.32%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    gastric perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haematemesis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    intestinal perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oesophageal perforation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    oesophageal spasm
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    4 / 40 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholangitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hepatic failure
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    bone pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    biliary sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lower respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    2 / 42 (4.76%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hyperkalaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ramucirumab Regimen 1 Ramucirumab Regimen 2 Ramucirumab Regimen 3 Ramucirumab Regimen 4
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 38 (78.95%)
    31 / 42 (73.81%)
    36 / 41 (87.80%)
    31 / 40 (77.50%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 38 (15.79%)
    2 / 42 (4.76%)
    7 / 41 (17.07%)
    6 / 40 (15.00%)
         occurrences all number
    8
    3
    8
    10
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 42 (7.14%)
    4 / 41 (9.76%)
    3 / 40 (7.50%)
         occurrences all number
    2
    3
    8
    4
    early satiety
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    3 / 42 (7.14%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    0
    6
    0
    1
    fatigue
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    10 / 38 (26.32%)
    12 / 42 (28.57%)
    6 / 41 (14.63%)
    9 / 40 (22.50%)
         occurrences all number
    12
    17
    7
    9
    oedema peripheral
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    4 / 42 (9.52%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
         occurrences all number
    1
    5
    2
    3
    pyrexia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    2 / 42 (4.76%)
    4 / 41 (9.76%)
    1 / 40 (2.50%)
         occurrences all number
    4
    2
    5
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 42 (7.14%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences all number
    4
    6
    1
    1
    dyspnoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    3 / 42 (7.14%)
    1 / 41 (2.44%)
    4 / 40 (10.00%)
         occurrences all number
    5
    4
    1
    4
    epistaxis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    2 / 42 (4.76%)
    6 / 41 (14.63%)
    2 / 40 (5.00%)
         occurrences all number
    1
    3
    7
    2
    pleural effusion
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 42 (0.00%)
    1 / 41 (2.44%)
    1 / 40 (2.50%)
         occurrences all number
    2
    0
    1
    1
    Psychiatric disorders
    insomnia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 42 (7.14%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
         occurrences all number
    1
    3
    2
    2
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 38 (7.89%)
    5 / 42 (11.90%)
    0 / 41 (0.00%)
    1 / 40 (2.50%)
         occurrences all number
    3
    7
    0
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 38 (15.79%)
    5 / 42 (11.90%)
    3 / 41 (7.32%)
    1 / 40 (2.50%)
         occurrences all number
    6
    8
    3
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    5 / 42 (11.90%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
         occurrences all number
    4
    5
    2
    1
    blood bilirubin increased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 38 (7.89%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    3
    0
    0
    0
    weight decreased
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 38 (7.89%)
    2 / 42 (4.76%)
    3 / 41 (7.32%)
    2 / 40 (5.00%)
         occurrences all number
    4
    2
    3
    2
    Injury, poisoning and procedural complications
    infusion related reaction
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 42 (0.00%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    6 / 42 (14.29%)
    5 / 41 (12.20%)
    3 / 40 (7.50%)
         occurrences all number
    8
    8
    8
    3
    lethargy
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    1
    0
    paraesthesia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    5 / 42 (11.90%)
    5 / 41 (12.20%)
    1 / 40 (2.50%)
         occurrences all number
    12
    15
    11
    1
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    3 / 40 (7.50%)
         occurrences all number
    0
    1
    1
    3
    abdominal pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 38 (15.79%)
    10 / 42 (23.81%)
    7 / 41 (17.07%)
    4 / 40 (10.00%)
         occurrences all number
    7
    14
    9
    8
    constipation
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    5 / 42 (11.90%)
    7 / 41 (17.07%)
    7 / 40 (17.50%)
         occurrences all number
    2
    8
    7
    7
    diarrhoea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 38 (7.89%)
    9 / 42 (21.43%)
    4 / 41 (9.76%)
    5 / 40 (12.50%)
         occurrences all number
    4
    12
    5
    5
    dyspepsia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    0 / 38 (0.00%)
    1 / 42 (2.38%)
    0 / 41 (0.00%)
    4 / 40 (10.00%)
         occurrences all number
    0
    1
    0
    4
    dysphagia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    1 / 38 (2.63%)
    3 / 42 (7.14%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
         occurrences all number
    1
    9
    2
    2
    nausea
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 38 (15.79%)
    4 / 42 (9.52%)
    4 / 41 (9.76%)
    7 / 40 (17.50%)
         occurrences all number
    7
    4
    5
    9
    vomiting
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    6 / 38 (15.79%)
    6 / 42 (14.29%)
    8 / 41 (19.51%)
    7 / 40 (17.50%)
         occurrences all number
    8
    7
    13
    10
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
         occurrences all number
    3
    2
    2
    1
    Renal and urinary disorders
    proteinuria
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    2 / 40 (5.00%)
         occurrences all number
    5
    1
    3
    2
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    3 / 42 (7.14%)
    1 / 41 (2.44%)
    2 / 40 (5.00%)
         occurrences all number
    5
    5
    2
    2
    muscular weakness
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    0 / 40 (0.00%)
         occurrences all number
    4
    1
    3
    0
    Infections and infestations
    nasopharyngitis
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    0 / 42 (0.00%)
    0 / 41 (0.00%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Metabolism and nutrition disorders
    decreased appetite
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    8 / 38 (21.05%)
    9 / 42 (21.43%)
    11 / 41 (26.83%)
    7 / 40 (17.50%)
         occurrences all number
    11
    16
    13
    8
    dehydration
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    2 / 38 (5.26%)
    1 / 42 (2.38%)
    1 / 41 (2.44%)
    4 / 40 (10.00%)
         occurrences all number
    3
    4
    2
    6
    hypoalbuminaemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    4 / 38 (10.53%)
    2 / 42 (4.76%)
    3 / 41 (7.32%)
    0 / 40 (0.00%)
         occurrences all number
    5
    2
    4
    0
    hyponatraemia
    alternative dictionary used: MedDRA 22.1
         subjects affected / exposed
    3 / 38 (7.89%)
    1 / 42 (2.38%)
    2 / 41 (4.88%)
    1 / 40 (2.50%)
         occurrences all number
    3
    1
    3
    3

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Apr 2015
    1. Inclusion and exclusion criteria regarding the use of anti coagulation therapy were amended; 2. Dose Modification, and its subsections, criteria for administration of ramucirumab to patients with hypertension were amended to align with other studies of ramucirumab in gastric cancer; 3. Safety monitoring, instructions for when to initiate monitoring of hepatic function were amended to align with lilly policy. 4. Short-Term and long term follow-up visits are modified.
    11 Dec 2015
    Revises the study's inclusion criteria to allow enrollment of patients who were previously treated with taxanes.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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