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    Clinical Trial Results:
    A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor

    Summary
    EudraCT number
    		 2018-004242-42
    Trial protocol
    		 FR   DE   ES   BE   IT  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jun 2025
    First version publication date
    28 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    J1S-MC-JV01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04145349
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 17305
    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
    Interim
    Date of interim/final analysis
    14 Jun 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jun 2024
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    This study is being conducted to test the safety and efficacy of ramucirumab in combination with other chemotherapy in the treatment of relapsed, recurrent, or refractory desmoplastic small round cell tumor (DSRCT) in children and young adults. This trial is part of the CAMPFIRE master protocol (NCT05999994) which is a platform to accelerate the development of new treatments for pediatric and young adult participants with cancer. Your participation in this trial could last 12 months or longer, depending on how you and your tumor respond.
    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
    22 Jan 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Italy: 4
    Country: Number of subjects enrolled
    United States: 9
    Country: Number of subjects enrolled
    Japan: 4
    Country: Number of subjects enrolled
    Australia: 1
    Worldwide total number of subjects
    30
    EEA total number of subjects
    10
    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)
    1
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    19
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Completers included participants who died due to any cause or were alive and on study at conclusion but off treatment.

    Pre-assignment
    Screening details
    		 No Text Available

    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 + Cyclophosphamide + Vinorelbine
    Arm description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15. Cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ramucirumab
    Investigational medicinal product code
    Other name
    LY3009806
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15 of a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28 of a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met.

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15 of a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met.

    Arm title
    		 Cyclophosphamide + Vinorelbine
    Arm description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28 of a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met.

    Investigational medicinal product name
    Vinorelbine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15 of a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met.

    Number of subjects in period 1
    		Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine
    Started
    20
    10
    Received at Least One Dose of Study Drug
    20
    10
    Completed
    17
    8
    Not completed
    3
    2
         Lost to Follow-up
    -
    1
         Withdrawal by Subject
    3
    -
         On study treatment (Ongoing)
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ramucirumab + Cyclophosphamide + Vinorelbine
    Reporting group description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15. Cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

    Reporting group title
    Cyclophosphamide + Vinorelbine
    Reporting group description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

    Reporting group values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine Total
    Number of subjects
    		 20 10 30
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 19.6 ( 5.67 ) 21.4 ( 5.06 ) -
    Gender categorical
    Units: Subjects
        Female
    		 5 0 5
        Male
    		 15 10 25
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 3 1 4
        Not Hispanic or Latino
    		 16 8 24
        Unknown or Not Reported
    		 1 1 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 4 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 4 1 5
        White
    		 13 4 17
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 1 2
    Region of Enrollment
    Units: Subjects
        United States
    		 5 4 9
        Japan
    		 1 3 4
        Italy
    		 3 1 4
        United Kingdom
    		 5 1 6
        Australia
    		 1 0 1
        Germany
    		 3 0 3
        Spain
    		 2 1 3

    End points

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    End points reporting groups
    Reporting group title
    Ramucirumab + Cyclophosphamide + Vinorelbine
    Reporting group description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Ramucirumab administered intravenously at a dose of 12 milligrams per kilogram (mg/kg) as a one-hour infusion on days 1 and 15. Cyclophosphamide administered orally at 25 milligrams per meter square (mg/m2) daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

    Reporting group title
    Cyclophosphamide + Vinorelbine
    Reporting group description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

    Primary: 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 randomization to the date of investigator-determined objective progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause in the absence of disease progression. Progressive disease (PD) was defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). Data are presented as the posterior median with 98% credible interval estimated using Bayesian analysis. Analysis Population Description (APD): All randomized participants who received at least 1 dose of study drug (including the censored participants).
    End point type
    Primary
    End point timeframe
    Randomization to Objective Progression or Death Due to Any Cause (Up To 23 Months)
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    20 [1]
    10 [2]
    Units: Months
        median (confidence interval 98%)
    5.69 (3.20 to 10.01)
    3.73 (1.76 to 8.29)
    Notes
    [1] - Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 4
    [2] - Number of participants censored in Cyclophosphamide + Vinorelbine = 2
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    The Bayesian analyses below include posterior mean of Hazard ratio, posterior probabilities instead of p-values, and credible intervals instead of confidence intervals.
    Comparison groups
    Ramucirumab + Cyclophosphamide + Vinorelbine v Cyclophosphamide + Vinorelbine
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.864
    Method
    		 Bayesian hierarchical model
    Parameter type
    		 Posterior Mean Hazard Ratio
    Point estimate
    0.69
    Confidence interval
         level
    		 98%
         sides
    2-sided
         lower limit
    		 0.25
         upper limit
    		 1.69

    Secondary: Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)

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    End point title
    		 Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
    End point description
    The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma.CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to <10 mm. Tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference. APD: All randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Randomization until measured progressive disease (Up To 23 Months)
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    20
    10
    Units: Percentage of participants
        number (confidence interval 80%)
    10 (2.7 to 24.5)
    10 (1.1 to 33.7)
    No statistical analyses for this end point

    Secondary: Duration of Response (DoR)

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    End point title
    		 Duration of Response (DoR)
    End point description
    DoR is defined as the time from the date that measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective disease progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of documented disease progression or recurrence .Participants known to be alive and without disease progression were censored at the date of their last adequate tumor assessment per RECIST 1.1 criteria, or date of randomization (whichever is later). APD: All randomized participants who received at least 1 dose of study drug and who had CR or PR responses (including the censored participants). Number of participants censored in Ramucirumab + Cyclophosphamide + Vinorelbine = 0, Cyclophosphamide + Vinorelbine = 1.
    End point type
    Secondary
    End point timeframe
    Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 23 Months)
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    2 [3]
    1 [4]
    Units: Months
        median (confidence interval 80%)
    9.55 (4.89 to 9999)
    9999 (9999 to 9999)
    Notes
    [3] - 9999=N/A= There were not enough events to estimate the upper limit of the 80% confidence interval.
    [4] - 9999=N/A=DoR couldn't be calculated as the participant did not achieve the event and was censored.
    No statistical analyses for this end point

    Secondary: Complete Response (CR) : Percentage of Participants Who Achieved a CR

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    End point title
    		 Complete Response (CR) : Percentage of Participants Who Achieved a CR
    End point description
    CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to <10 mm. Tumor marker results were required to have normalized. All randomized participants who received at least one dose of study drug. APD:All randomized participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Randomization until measured progressive disease (Up To 23 Months)
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    20
    10
    Units: Percentage of participants
        number (confidence interval 80%)
    5.0 (0.5 to 18.1)
    0 (0.0 to 20.6)
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax)

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    End point title
    		 Pharmacokinetics (PK): Maximum Serum Concentration of Ramucirumab (Cmax) [5]
    End point description
    Cmax was the concentration of study drug in the blood after the dose is administered. It was measured post-dose and was summarized using descriptive statistics. APD: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome.
    End point type
    Secondary
    End point timeframe
    End of ramucirumab infusion on Day 1 of Cycle 1
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome is planned for Ramucirumab arm only.
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    14
    Units: microgram per milliliter (µg/mL)
        geometric mean (geometric coefficient of variation)
    238 ( 35 )
    No statistical analyses for this end point

    Secondary: PK: Minimum Serum Concentration of Ramucirumab (Cmin)

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    End point title
    		 PK: Minimum Serum Concentration of Ramucirumab (Cmin) [6]
    End point description
    Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics. APD: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data for this outcome. Number analyzed refers to participants evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Prior to ramucirumab infusion on - Day 15 of Cycle 1 and Day 1 of Cycles 2, 4, 7, and 10
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome is planned for Ramucirumab arm only.
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    13 [7]
    Units: microgram per milliliter (µg/mL)
    geometric mean (geometric coefficient of variation)
        Day 15 of Cycle 1, Number Analyzed = 13
    41.6 ( 57 )
        Day 1 of Cycle 2 , Number Analyzed = 9
    88.7 ( 47 )
        Day 1 of Cycle 4 , Number Analyzed = 7
    157 ( 37 )
        Day 1 of Cycle 7 , Number Analyzed = 4
    155 ( 28 )
        Day 1 of Cycle 10 , Number Analyzed = 2
    9999 ( 9999 )
    Notes
    [7] - 9999=N/A due to insufficient participants. Individual values reported: 151 µg/mL, 207 µg/mL.
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)

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    End point title
    		 Number of Participants With Treatment-Emergent Anti-Drug Antibodies (TE-ADA)
    End point description
    A TE-ADA evaluable participant is considered TE-ADA positive if they have at least one post-baseline ADA titer that is a 4-fold or greater increase from their baseline titer (treatment-boosted); alternatively, if the baseline ADA result is Not Present, the participant is considered TE-ADA positive if there is at least one post-baseline ADA result that is Present with a titer greater than or equal to 1:20 (treatment-induced). APD: All randomized participants who received at least one dose of study drug and had at least one non-missing baseline, post baseline ADA value.
    End point type
    Secondary
    End point timeframe
    Baseline Up to 23 months
    End point values
    		 Ramucirumab + Cyclophosphamide + Vinorelbine Cyclophosphamide + Vinorelbine
    Number of subjects analysed
    13
    5
    Units: participants
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up to 23 months
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug. Participants were analyzed based on the actual treatment they received. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Cyclophosphamide + Vinorelbine
    Reporting group description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

    Reporting group title
    Ramucirumab + Cyclophosphamide + Vinorelbine
    Reporting group description
    		 Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.

    Serious adverse events
    		 Cyclophosphamide + Vinorelbine Ramucirumab + Cyclophosphamide + Vinorelbine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    6 / 20 (30.00%)
         number of deaths (all causes)
    7
    12
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    post procedural haemorrhage
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vascular access complication
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    syncope
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pyrexia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    febrile neutropenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    ascites
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    nausea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    bacteraemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cystitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    device related infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    viral diarrhoea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cyclophosphamide + Vinorelbine Ramucirumab + Cyclophosphamide + Vinorelbine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    20 / 20 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    tumour pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    thrombosis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    phlebitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    superficial vein thrombosis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    4
    2
    chills
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    catheter site rash
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    fatigue
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    5 / 20 (25.00%)
         occurrences all number
    3
    6
    early satiety
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    mucosal inflammation
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    4 / 20 (20.00%)
         occurrences all number
    0
    4
    impaired healing
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    localised oedema
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    malaise
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    non-cardiac chest pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    thirst
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    pyrexia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 10 (40.00%)
    5 / 20 (25.00%)
         occurrences all number
    7
    7
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    seasonal allergy
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    type iv hypersensitivity reaction
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    vaginal discharge
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed [1]
    0 / 10 (0.00%)
    1 / 5 (20.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    6 / 20 (30.00%)
         occurrences all number
    2
    6
    epistaxis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    8 / 20 (40.00%)
         occurrences all number
    0
    11
    dyspnoea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    oropharyngeal pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    nasal congestion
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    rhinitis allergic
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    tachypnoea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    confusional state
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    insomnia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Product issues
    device dislocation
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Investigations
    anion gap decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    activated partial thromboplastin time prolonged
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    2
    3
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    10 / 20 (50.00%)
         occurrences all number
    7
    15
    blood urea increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    6
    blood thyroid stimulating hormone increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    blood creatinine increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    11
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    7 / 20 (35.00%)
         occurrences all number
    7
    11
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    4 / 20 (20.00%)
         occurrences all number
    1
    6
    blood bilirubin increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    blood chloride decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    blood creatine increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    glomerular filtration rate decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    haemoglobin increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    international normalised ratio increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    lymphocyte count decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 10 (30.00%)
    5 / 20 (25.00%)
         occurrences all number
    9
    7
    neutrophil count decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    5 / 10 (50.00%)
    10 / 20 (50.00%)
         occurrences all number
    22
    33
    platelet count decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    2
    14
    weight decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    weight increased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    white blood cell count decreased
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    6 / 10 (60.00%)
    11 / 20 (55.00%)
         occurrences all number
    26
    39
    Injury, poisoning and procedural complications
    infusion related reaction
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    limb injury
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    wound complication
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    tachycardia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    sinus tachycardia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    dizziness
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    dysgeusia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    headache
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    10 / 20 (50.00%)
         occurrences all number
    1
    17
    neuropathy peripheral
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    peripheral sensory neuropathy
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    8 / 20 (40.00%)
         occurrences all number
    13
    13
    febrile neutropenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    leukopenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    lymphopenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    neutropenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    11 / 20 (55.00%)
         occurrences all number
    3
    28
    thrombocytopenia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    Eye disorders
    eye swelling
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    ocular hyperaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    abdominal distension
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 20 (10.00%)
         occurrences all number
    4
    2
    abdominal pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    11 / 20 (55.00%)
         occurrences all number
    2
    18
    ascites
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    constipation
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 10 (30.00%)
    7 / 20 (35.00%)
         occurrences all number
    3
    7
    anorectal discomfort
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    dry mouth
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    diarrhoea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    7 / 20 (35.00%)
         occurrences all number
    1
    12
    eructation
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    dyspepsia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    flatulence
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    gastritis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    gingival bleeding
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    gingival pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    haemorrhoids
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    nausea
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 10 (30.00%)
    4 / 20 (20.00%)
         occurrences all number
    7
    6
    stomatitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    4
    vomiting
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    4 / 10 (40.00%)
    6 / 20 (30.00%)
         occurrences all number
    4
    11
    Skin and subcutaneous tissue disorders
    dry skin
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    eczema
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    5
    petechiae
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    skin ulcer
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    rash
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    dysuria
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    haematuria
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    micturition urgency
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    pollakiuria
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    proteinuria
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    9 / 20 (45.00%)
         occurrences all number
    0
    14
    Endocrine disorders
    hypothyroidism
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    back pain
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    7 / 20 (35.00%)
         occurrences all number
    3
    7
    myalgia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    muscular weakness
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    pain in extremity
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    3
    cellulitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    cystitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    ear lobe infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    gingivitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    klebsiella infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    oral herpes
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    skin infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    urinary tract infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    wound infection
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    decreased appetite
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    3 / 10 (30.00%)
    2 / 20 (10.00%)
         occurrences all number
    3
    2
    hypercalcaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    hyperglycaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    hyperkalaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    hypermagnesaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    hypernatraemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    hyperphosphataemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    7
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    hypoalbuminaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    7
    hypocalcaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    12
    hypoglycaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    3
    hyponatraemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    5 / 20 (25.00%)
         occurrences all number
    3
    7
    hypomagnesaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    3
    hypokalaemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    hypophosphataemia
    alternative dictionary used: MedDRA 27.0
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Notes
    [1] - 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: Gender specific events only occurring in female participants have had the number of participants At Risk adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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