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    Clinical Trial Results:
    An Open-Label, Multi-Center Safety and Tolerability Pilot Combination Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Patients with Acute Lymphoblastic Leukemia (ALL) in First Relapse

    Summary
    EudraCT number
    2015-001173-41
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    26 Apr 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    23 May 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLO08808
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00991133
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street, Cambridge, MA, United States, 02142
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    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
    26 Apr 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Apr 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the safety of 1 cycle of the 5-drug regimen in pediatric subjects with acute lymphoblastic leukemia (ALL) who were in first bone marrow relapse.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates. The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    08 Jan 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    4 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 8
    Worldwide total number of subjects
    8
    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)
    0
    Children (2-11 years)
    4
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 6 centers in United States of America. A total of 8 subjects were screened between 08 January 2010 and 10 November 2010.

    Pre-assignment
    Screening details
    All subjects were treated.

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

    Arms
    Arm title
    Overall Population
    Arm description
    Subjects received 5 drug regimen: clofarabine, etoposide, cyclophosphamide (Days 1-5), PEG-asparaginase (Day 15) and vincristine (Days 15-22) in each 28 day cycle for maximum 2 cycles. Subjects who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and subjects who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion.
    Arm type
    Experimental

    Investigational medicinal product name
    Clofarabine
    Investigational medicinal product code
    Other name
    Clolar
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg/m²

    Investigational medicinal product name
    Etoposide
    Investigational medicinal product code
    Other name
    VP-16
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg/m²

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Cytoxan
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    440 mg/m²

    Investigational medicinal product name
    PEG-asparaginase
    Investigational medicinal product code
    Other name
    PEGaspar-aginase
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    2500 IU/m²

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Oncovin
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.5 mg/m² (maximum dose 2 mg)

    Number of subjects in period 1
    Overall Population
    Started
    8
    Completed
    0
    Not completed
    8
         Sponsor or Investigator decision
             2
         Adverse event or treatment toxicity
             2
         Subject scheduled to receive transplant or therapy
             2
         Consent withdrawn by subject
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Population
    Reporting group description
    Subjects received 5 drug regimen: clofarabine, etoposide, cyclophosphamide (Days 1-5), PEG-asparaginase (Day 15) and vincristine (Days 15-22) in each 28 day cycle for maximum 2 cycles. Subjects who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and subjects who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion.

    Reporting group values
    Overall Population Total
    Number of subjects
    8 8
    Age categorical
    Units: Subjects
        Children (2-11 years)
    4 4
        Adolescents (12-17 years)
    2 2
        Adults (18-64 years)
    2 2
    Gender categorical
    Units: Subjects
        Female
    6 6
        Male
    2 2

    End points

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    End points reporting groups
    Reporting group title
    Overall Population
    Reporting group description
    Subjects received 5 drug regimen: clofarabine, etoposide, cyclophosphamide (Days 1-5), PEG-asparaginase (Day 15) and vincristine (Days 15-22) in each 28 day cycle for maximum 2 cycles. Subjects who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and subjects who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion.

    Primary: Number of Subjects Who Experienced Dose Limiting Toxicity

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    End point title
    Number of Subjects Who Experienced Dose Limiting Toxicity [1]
    End point description
    All enrolled subjects were analysed.
    End point type
    Primary
    End point timeframe
    Cycle 1
    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 analysis was performed as the analysis was descriptive.
    End point values
    Overall Population
    Number of subjects analysed
    8
    Units: subjects
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects with Complete Remission (CR)

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    End point title
    Number of Subjects with Complete Remission (CR)
    End point description
    All enrolled subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Cycle 1
    End point values
    Overall Population
    Number of subjects analysed
    8
    Units: subjects
    3
    No statistical analyses for this end point

    Secondary: Disease-Free Survival (DFS)

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    End point title
    Disease-Free Survival (DFS)
    End point description
    DFS was defined as time from date of first objective documentation of CR until the earlier of date of objective documentation of disease relapse or date of death due to any cause, regardless of intervening alternative anti-leukemic therapy ( including hematopoietic stem cell transplant). Analysis was performed on subjects who achieved CR.
    End point type
    Secondary
    End point timeframe
    First objective documentation of CR until the earlier of date of objective documentation of disease relapse or date of death due to any cause
    End point values
    Overall Population
    Number of subjects analysed
    0 [2]
    Units: weeks
        number (not applicable)
    Notes
    [2] - No summary analyses performed. No efficacy conclusion could be drawn due to small number of subjects
    No statistical analyses for this end point

    Secondary: Time to Remission and Duration of Remission

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    End point title
    Time to Remission and Duration of Remission
    End point description
    Time to remission was defined as time from date of first administration of study drugs until date of first objective documentation of CR. Analysis was performed on subjects who achieved CR.
    End point type
    Secondary
    End point timeframe
    Baseline up to first objective documentation of CR
    End point values
    Overall Population
    Number of subjects analysed
    0 [3]
    Units: weeks
        number (not applicable)
    Notes
    [3] - No summary analyses performed. No efficacy conclusion could be drawn due to small number of subjects
    No statistical analyses for this end point

    Secondary: Event-Free Survival (EFS)

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    End point title
    Event-Free Survival (EFS)
    End point description
    EFS was defined as time from date of first administration of study drugs until the earliest date of death due to any cause, occurrence of a treatment-related secondary neoplasm, first response assessment confirming relapse (for subjects who achieved CR); or final response assessment that failed to confirm response (CR). All enrolled subjects were analysed
    End point type
    Secondary
    End point timeframe
    Baseline up to death due to any cause, treatment-related secondary neoplasm, first response assessment confirming relapse (for subjects who achieved CR); or final response assessment that failed to confirm response, whichever occurred first
    End point values
    Overall Population
    Number of subjects analysed
    0 [4]
    Units: weeks
        number (not applicable)
    Notes
    [4] - No summary analyses performed. No efficacy conclusion could be drawn due to small number of subjects
    No statistical analyses for this end point

    Secondary: Overall Survival

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    End point title
    Overall Survival
    End point description
    Time from date of first administration of study drugs until date of death due to any cause. All enrolled subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline up to death due to any cause
    End point values
    Overall Population
    Number of subjects analysed
    0 [5]
    Units: weeks
        number (not applicable)
    Notes
    [5] - No summary analyses performed. No efficacy conclusion could be drawn due to small number of subjects
    No statistical analyses for this end point

    Secondary: Number of subjects who achieved 4-Months EFS

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    End point title
    Number of subjects who achieved 4-Months EFS
    End point description
    Four-month events free survival: Duration of EFS was at least 4 months post initial administration of the 5-drug regimen. All enrolled subjects were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 months
    End point values
    Overall Population
    Number of subjects analysed
    8
    Units: subjects
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (cycle 1) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events and deaths are treatment-emergent that is AEs that developed/worsened during the ‘on treatment period’ (from the first dose study drugs up to last dose of study drug).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Overall Population
    Reporting group description
    Subjects received 5 drug regimen: clofarabine, etoposide, cyclophosphamide (Days 1-5), PEG-asparaginase (Day 15) and vincristine (Days 15-22) in each 28 day cycle for maximum 2 cycles. Subjects who achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp) after 1 cycle of study drugs were eligible to receive a second cycle of study drugs upon recovery of peripheral blood counts, and subjects who did not have leukemic progression were eligible to receive a second treatment cycle at the investigator's discretion.

    Serious adverse events
    Overall Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 8 (50.00%)
         number of deaths (all causes)
    4
         number of deaths resulting from adverse events
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Blood Bilirubin Increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Lipase Increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Bone Marrow Failure
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Leukoencephalopathy
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Fungal Skin Infection
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterococcal Bacteraemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia Fungal
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    Pneumonia Respiratory Syncytial Viral
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Overall Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 8 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    3
    Haematoma
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Thrombosis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Hypotension
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Poor Peripheral Circulation
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour Pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Immune system disorders
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Generalised Oedema
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Chills
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    5
    Chest Pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Mucosal Inflammation
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Pyrexia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    4
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Disorientation
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Confusional State
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Anxiety
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vulvovaginal Pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Ovarian Cyst
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Allergic Transfusion Reaction
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Transfusion Reaction
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Investigations
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    3
    Blood Alkaline Phosphatase Increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood Bilirubin Increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood Triglycerides Increased
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Blood Amylase Increased
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    3
    Enterococcus Test Positive
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gallop Rhythm Present
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Mycobacterium Test Positive
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Specific Gravity Urine Abnormal
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Lipase Increased
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    3
    Weight Increased
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Cardiac disorders
    Pericardial Haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Dyspnoea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Haemoptysis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Pleural Effusion
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Tachypnoea
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    4
    Anaemia
         subjects affected / exposed
    7 / 8 (87.50%)
         occurrences all number
    17
    Lymphopenia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Pancytopenia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Febrile Neutropenia
         subjects affected / exposed
    5 / 8 (62.50%)
         occurrences all number
    5
    Splenic Necrosis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    4
    Thrombocytopenia
         subjects affected / exposed
    6 / 8 (75.00%)
         occurrences all number
    9
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    4
    Tremor
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Eye disorders
    Ocular Hyperaemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vitreous Floaters
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Diplopia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Photophobia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    6 / 8 (75.00%)
         occurrences all number
    7
    Chapped Lips
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Anal Erosion
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    5 / 8 (62.50%)
         occurrences all number
    5
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    8 / 8 (100.00%)
         occurrences all number
    10
    Pancreatitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Gingival Bleeding
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Proctalgia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Rectal Fissure
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    7 / 8 (87.50%)
         occurrences all number
    10
    Renal and urinary disorders
    Glycosuria
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Dysuria
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Haematuria
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Haemoglobinuria
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Pollakiuria
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Proteinuria
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    4
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    3
    Hepatomegaly
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Drug Eruption
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Blister
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    7
    Dry Skin
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Palmar Erythema
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Night Sweats
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Pruritus Generalised
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Rash Generalised
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Purpura
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    6
    Skin Exfoliation
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Pain In Extremity
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Musculoskeletal Pain
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Hyperamylasaemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    2
    Decreased Appetite
         subjects affected / exposed
    7 / 8 (87.50%)
         occurrences all number
    9
    Hyperuricaemia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Hyperglycaemia
         subjects affected / exposed
    3 / 8 (37.50%)
         occurrences all number
    5
    Hypocalcaemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    5
    Hypomagnesaemia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Hyponatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    4 / 8 (50.00%)
         occurrences all number
    5
    Hypophosphataemia
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Infections and infestations
    Bk Virus Infection
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Endocarditis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    2 / 8 (25.00%)
         occurrences all number
    2
    Psoas Abscess
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    1 / 8 (12.50%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2010
    Seven subjects were enrolled under the original protocol, and 1 subject was enrolled under the amended protocol.

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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