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    Clinical Trial Results:
    ONO-7847 Japanese Clinical Study in Pediatric Patients: Multicenter, Open-label, Uncontrolled Study for the Prevention of CINV

    Summary
    EudraCT number
    		 2018-000663-80
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jul 2018
    First version publication date
    15 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ONO-7847-03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ONO Pharmaceutical Co., Ltd.
    Sponsor organisation address
    8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka, Japan, 541-8564
    Public contact
    Clinical Development Planning, ONO Pharmaceutical Co., Ltd., 06 6263-3902,
    Scientific contact
    Clinical Development Planning, ONO Pharmaceutical Co., Ltd., 06 6263-3902,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to confirm the safety, efficacy, and pharmacokinetics (PK) of ONO-7847 (fosaprepitant dimeglumine) when used for the prevention of chemotherapy-induced nausea and vomiting (CINV) in Japanese pediatric participants with malignant tumors who were scheduled to receive chemotherapy including any cisplatin, cyclophosphamide, or carboplatin.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. The following additional measure defined for this individual study was in place for the protection of study participants: Investigator-prescribed rescue therapy medication was allowed for the treatment of emergent nausea and vomiting.
    Background therapy
    		 Acceptable rescue therapy medications for severe nausea (inability to ingest food or water) included: 5-Hydroxytryptamine (5-HT3) receptor antagonists (granisetron, ondansetron, azasetron); Phenothiazines (chlorpromazine, prochlorperazine, perphenazine); Butyrophenones (haloperidol, droperidol); Benzamides (sulpiride, tiapride, sultopride); Dopamine receptor antagonists (metoclopramide, itopride, domperidone); Corticosteroids (dexamethasone, methylprednisolone); Benzodiazepines (diazepam, nitrazepam, triazolam) and/or Antihistamines (hydroxyzine, dimenhydrinate, diphenhydramine).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 27
    Worldwide total number of subjects
    27
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    5
    Children (2-11 years)
    10
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Japanese pediatric participants, aged 6 months to 18 years, with malignant tumors who were scheduled to receive emetogenic chemotherapy were recruited for this study.

    Pre-assignment
    Screening details
    		 Participants were divided into the following four age brackets: 6 months to <2 years; 2 years to <6 years; 6 years to <12 years and 12 years to 18 years.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ONO-7847: 6 mos to <2 yrs
    Arm description
    		 Participants aged 6 mos to <2 yrs received a single administration of ONO-7847 3 mg/kg via intravenous (IV) infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ONO-7847
    Investigational medicinal product code
    Other name
    fosaprepitant dimegulmine
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg to 150 mg, depending on age of participant

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    KYTRIL®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 ug/kg

    Investigational medicinal product name
    Dexamethasone phosphate
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.1 mg/kg to 4 mg, depending on age of participant

    Arm title
    		 ONO-7847: 2 yrs to <6 yrs
    Arm description
    		 Participants aged 2 yrs to <6 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ONO-7847
    Investigational medicinal product code
    Other name
    fosaprepitant dimegulmine
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg to 150 mg, depending on age of participant

    Investigational medicinal product name
    Dexamethasone phosphate
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.1 mg/kg to 4 mg, depending on age of participant

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    KYTRIL®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 ug/kg

    Arm title
    		 ONO-7847: 6 yrs to <12 yrs
    Arm description
    		 Participants aged 6 yrs to <12 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ONO-7847
    Investigational medicinal product code
    Other name
    fosaprepitant dimegulmine
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg to 150 mg, depending on age of participant

    Investigational medicinal product name
    Dexamethasone phosphate
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.1 mg/kg to 4 mg, depending on age of participant

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    KYTRIL®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 ug/kg

    Arm title
    		 ONO-7847: 12 yrs to 18 yrs
    Arm description
    		 Participants aged 12 yrs to 18 yrs received a single administration of ONO-7847 150 mg via IV infusion on Day 1 PLUS dexamethasone 4 mg via IV infusion on Days 1-2 and 8 mg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ONO-7847
    Investigational medicinal product code
    Other name
    fosaprepitant dimegulmine
    Pharmaceutical forms
    Powder for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    3 mg/kg to 150 mg, depending on age of participant

    Investigational medicinal product name
    Granisetron
    Investigational medicinal product code
    Other name
    KYTRIL®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 ug/kg

    Investigational medicinal product name
    Dexamethasone phosphate
    Investigational medicinal product code
    Other name
    DECADRON®
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.1 mg/kg to 4 mg, depending on age of participant

    Number of subjects in period 1
    		ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs
    Started
    5
    5
    5
    12
    Completed
    5
    5
    5
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ONO-7847: 6 mos to <2 yrs
    Reporting group description
    		 Participants aged 6 mos to <2 yrs received a single administration of ONO-7847 3 mg/kg via intravenous (IV) infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 2 yrs to <6 yrs
    Reporting group description
    		 Participants aged 2 yrs to <6 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 6 yrs to <12 yrs
    Reporting group description
    		 Participants aged 6 yrs to <12 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 12 yrs to 18 yrs
    Reporting group description
    		 Participants aged 12 yrs to 18 yrs received a single administration of ONO-7847 150 mg via IV infusion on Day 1 PLUS dexamethasone 4 mg via IV infusion on Days 1-2 and 8 mg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group values
    		 ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs Total
    Number of subjects
    		 5 5 5 12 27
    Age Categorical
    Units: Subjects
        Infants and toddlers (28 days-23 months)
    		 5 0 0 0 5
        Children (2-11 years)
    		 0 5 5 0 10
        Adolescents (12-17 years)
    		 0 0 0 12 12
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 0.96 ( 0.09 ) 3.60 ( 1.14 ) 9.00 ( 1.87 ) 15.42 ( 1.51 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 2 2 3 2 9
        Male
    		 3 3 2 10 18

    End points

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    End points reporting groups
    Reporting group title
    ONO-7847: 6 mos to <2 yrs
    Reporting group description
    		 Participants aged 6 mos to <2 yrs received a single administration of ONO-7847 3 mg/kg via intravenous (IV) infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 2 yrs to <6 yrs
    Reporting group description
    		 Participants aged 2 yrs to <6 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 6 yrs to <12 yrs
    Reporting group description
    		 Participants aged 6 yrs to <12 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 12 yrs to 18 yrs
    Reporting group description
    		 Participants aged 12 yrs to 18 yrs received a single administration of ONO-7847 150 mg via IV infusion on Day 1 PLUS dexamethasone 4 mg via IV infusion on Days 1-2 and 8 mg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Primary: Percentage of Participants With A Complete Response (No Vomiting and No Use of Rescue Therapy)

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    End point title
    		 Percentage of Participants With A Complete Response (No Vomiting and No Use of Rescue Therapy) [1]
    End point description
    A Complete Response (CR) was defined as no vomiting and no use of rescue therapy. The percentage of participants who experienced a CR is presented by treatment phase (Overall Phase: 0-120 hr, Acute Phase: 0-24 hr and Delayed Phase: 24-120 hr), where “0 hours” was defined as the start of the initial moderately or highly emetogenic chemotherapy on Day 1. The analysis population consisted of all participants who met key enrollment criteria, received ≥1 dose of both granisetron and dexamethasone, received any cisplatin, cyclophosphamide, or carboplatin, received ≥1 dose of ONO-7847 and had ≥1 post-treatment efficacy observation.
    End point type
    Primary
    End point timeframe
    Up to 120 hours after start of emetogenic chemotherapy (Up to 5 days)
    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 statistical analyses were planned for or conducted on this primary end point.
    End point values
    		 ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs
    Number of subjects analysed
    5
    5
    5
    12
    Units: Percentage of Participants
    number (confidence interval 95%)
        Overall Phase (0-120 hr)
    80.0 (28.4 to 99.5)
    40.0 (5.3 to 85.3)
    40.0 (5.3 to 85.3)
    25.0 (5.5 to 57.2)
        Acute Phase (0-24 hr)
    80.0 (28.4 to 99.5)
    80.0 (28.4 to 99.5)
    100.0 (47.8 to 100.0)
    75.0 (42.8 to 94.5)
        Delayed Phase (24-120 hr)
    100.0 (47.8 to 100.0)
    40.0 (5.3 to 85.3)
    40.0 (5.3 to 85.3)
    25.0 (5.5 to 57.2)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced an Adverse Drug Reaction (ADR)

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    End point title
    		 Percentage of Participants Who Experienced an Adverse Drug Reaction (ADR) [2]
    End point description
    Adverse events (AEs) for which a causal relationship could not be ruled out (i.e., those with a causal relationship of Definitely, Probably or Possibly related to study treatment) were to be handled as "adverse drug reactions" (ADRs). The percentage of participants who experienced an ADR is presented. The analysis population consisted of all allocated participants who received 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    Up to 14 days postdose (Up to 15 days)
    Notes
    [2] - 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 statistical analyses were planned for or conducted on this primary end point.
    End point values
    		 ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs
    Number of subjects analysed
    5
    5
    5
    12
    Units: Percentage of Participants
        number (not applicable)
    20.0
    20.0
    20.0
    8.3
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Discontinued Study Treatment Due to an ADR

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    End point title
    		 Percentage of Participants Who Discontinued Study Treatment Due to an ADR [3]
    End point description
    AEs for which a causal relationship could not be ruled out (i.e., those with a causal relationship of Definitely, Probably or Possibly related to study treatment) were to be handled as ADRs. The percentage of participants who discontinued study treatment due to an ADR is presented. The analysis population consisted of all allocated participants who received 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    Day 1
    Notes
    [3] - 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 statistical analyses were planned for or conducted on this primary end point.
    End point values
    		 ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs
    Number of subjects analysed
    5
    5
    5
    12
    Units: Percentage of Participants
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days postdose (Up to 15 days)
    Adverse event reporting additional description
    The analysis population consisted of all allocated participants who received 1 dose of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0J
    Reporting groups
    Reporting group title
    ONO-7847: 6 mos to <2 yrs
    Reporting group description
    		 Participants aged 6 mos to <2 yrs received a single administration of ONO-7847 3 mg/kg via intravenous (IV) infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 2 yrs to <6 yrs
    Reporting group description
    		 Participants aged 2 yrs to <6 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 6 yrs to <12 yrs
    Reporting group description
    		 Participants aged 6 yrs to <12 yrs received a single administration of ONO-7847 3 mg/kg via IV infusion on Day 1 PLUS dexamethasone 0.1 mg/kg via IV infusion on Days 1-2 and 0.2 mg/kg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Reporting group title
    ONO-7847: 12 yrs to 18 yrs
    Reporting group description
    		 Participants aged 12 yrs to 18 yrs received a single administration of ONO-7847 150 mg via IV infusion on Day 1 PLUS dexamethasone 4 mg via IV infusion on Days 1-2 and 8 mg on Day 3 PLUS granisetron 40 ug/kg via IV infusion on Days 1-5.

    Serious adverse events
    		 ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         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
    		 ONO-7847: 6 mos to <2 yrs ONO-7847: 2 yrs to <6 yrs ONO-7847: 6 yrs to <12 yrs ONO-7847: 12 yrs to 18 yrs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    12 / 12 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Embolism
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    General disorders and administration site conditions
    Face oedema
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    2 / 5 (40.00%)
    2 / 5 (40.00%)
    5 / 5 (100.00%)
    4 / 12 (33.33%)
         occurrences all number
    2
    2
    5
    4
    Oedema peripheral
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Catheter site erythema
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Catheter site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Puncture site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Hiccups
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    0
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    3 / 5 (60.00%)
    1 / 5 (20.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    3
    1
    2
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    2
    1
    1
    Blood bilirubin increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Blood chloride decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood cholesterol increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood potassium decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood sodium decreased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    0
    1
    Glucose urine present
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    3 / 5 (60.00%)
    4 / 5 (80.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    4
    1
    0
    Heart rate increased
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Lymphocyte count decreased
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    11 / 12 (91.67%)
         occurrences all number
    6
    5
    5
    13
    Neutrophil count decreased
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    10 / 12 (83.33%)
         occurrences all number
    5
    5
    5
    10
    Platelet count decreased
         subjects affected / exposed
    2 / 5 (40.00%)
    4 / 5 (80.00%)
    4 / 5 (80.00%)
    6 / 12 (50.00%)
         occurrences all number
    2
    4
    4
    6
    Red blood cell count decreased
         subjects affected / exposed
    3 / 5 (60.00%)
    4 / 5 (80.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    3
    4
    1
    0
    Weight decreased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    1
    2
    0
    Weight increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    5 / 5 (100.00%)
    10 / 12 (83.33%)
         occurrences all number
    5
    5
    5
    11
    Urine ketone body present
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Headache
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    3 / 5 (60.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    3
    4
    Hypoaesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 5 (80.00%)
    5 / 5 (100.00%)
    4 / 5 (80.00%)
    5 / 12 (41.67%)
         occurrences all number
    4
    5
    4
    5
    Febrile neutropenia
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    2 / 5 (40.00%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    2
    2
    Ear and labyrinth disorders
    Hearing impaired
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Eyelid oedema
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    0
    1
    Constipation
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    0
    2
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 5 (40.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Dyspepsia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Lip dry
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lip ulceration
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 5 (20.00%)
    5 / 12 (41.67%)
         occurrences all number
    0
    1
    1
    5
    Proctalgia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    4 / 5 (80.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    4
    1
    Vomiting
         subjects affected / exposed
    1 / 5 (20.00%)
    2 / 5 (40.00%)
    2 / 5 (40.00%)
    4 / 12 (33.33%)
         occurrences all number
    1
    4
    3
    5
    Gastrointestinal hypomotility
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis acneiform
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nail discolouration
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain of skin
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oliguria
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urethral pain
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    1
    Myositis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Pain in jaw
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nasopahryngitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Periodontitis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Wound infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Clostridium difficile infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 5 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    0
    0
    0
    2
    Hyponatraemia
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    1 / 5 (20.00%)
    4 / 12 (33.33%)
         occurrences all number
    0
    0
    1
    4
    Decreased appetite
         subjects affected / exposed
    2 / 5 (40.00%)
    1 / 5 (20.00%)
    3 / 5 (60.00%)
    5 / 12 (41.67%)
         occurrences all number
    2
    1
    3
    5

    More information

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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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    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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