Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35335   clinical trials with a EudraCT protocol, of which   5785   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase I/II Study of Lenalidomide in Patients with Chronic Myelomonocytic Leukemia

    Summary
    EudraCT number
    2009-017147-33
    Trial protocol
    AT  
    Global end of trial date
    08 Feb 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    21 May 2017
    First version publication date
    25 Feb 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Provide more detailed data regarding subject disposition

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    AGMT_CMML1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01368757
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AGMT
    Sponsor organisation address
    Gentzgasse 60/20, Wien, Austria, 1180
    Public contact
    Daniela Wolkersdorfer, AGMT gemeinnützige GmbH, +43 6641422504, d.wolkersdorfer@agmt.at
    Scientific contact
    Richard Greil, AGMT gemeinnützige GmbH, +43 00435725525801, r.greil@salk.at
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Phase I: The primary objective of the phase I trial is to determine the MTD (maximum tolerated dose) of lenalidomide. Phase II: The primary objective of the phase II trial is to determine the hematologic response achieved with lenalidomide administered in subjects at the MTD determined in phase I.
    Protection of trial subjects
    Safety assessments were done weekly in cycle 1, every second week in cycle 2 and on day 1 of the following cycles. Patients were counselled before each cycle of Lenalidomide e.g. about pregnancy precautions and the potential risks of fetal exposure to Lenalidomide.
    Background therapy
    None.
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Jul 2010
    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
    Austria: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    3
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Between July 2010 and January 2014 20 patients were recruited at 8 sites in Austria. Patients were enrolled using a traditional "3+3 " design. Due to the very prolonged recruitment period in phase I, it was discussed and decided not to start phase II of the study. No further patients will were enrolled into AGMT_CMML 1.

    Pre-assignment
    Screening details
    Eligible patients had a confirmed diagnosis of CMML according to the WHO criteria. Pretreatment was permitted.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Cohort 5 mg
    Arm description
    Daily dose of lenalidomide: 5 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide (5 mg) was administered daily in a 28 days cycle. All subjects were planned to continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.

    Arm title
    Cohort 10 mg
    Arm description
    Daily dose of lenalidomide: 10 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide (10 mg) was administered daily in a 28 days cycle. All subjects were planned to continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.

    Arm title
    Cohort 15 mg
    Arm description
    Daily dose of lenalidomide: 15 mg.
    Arm type
    Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Revlimid
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide (15 mg) was administered daily in a 28 days cycle. All subjects were planned to continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.

    Number of subjects in period 1
    Cohort 5 mg Cohort 10 mg Cohort 15 mg
    Started
    6
    6
    8
    Completed
    2
    1
    1
    Not completed
    4
    5
    7
         Death
             -
             -
             1
         Physician decision
             -
             -
             1
         Adverse event, serious fatal
             -
             -
             1
         Recurrent infections
             -
             1
             -
         Blastic plasmocytoide dendritic neoplasia
             -
             1
             -
         Adverse event, non-fatal
             3
             2
             4
         No further dose reduction possible
             1
             -
             -
         Transformation to AML
             -
             1
             -

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Reporting group values
    Overall trial Total
    Number of subjects
    20 20
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    72 (59 to 81) -
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    17 17

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Cohort 5 mg
    Reporting group description
    Daily dose of lenalidomide: 5 mg.

    Reporting group title
    Cohort 10 mg
    Reporting group description
    Daily dose of lenalidomide: 10 mg.

    Reporting group title
    Cohort 15 mg
    Reporting group description
    Daily dose of lenalidomide: 15 mg.

    Primary: Evaluation of maximum tolerated dose (MTD)

    Close Top of page
    End point title
    Evaluation of maximum tolerated dose (MTD) [1]
    End point description
    The MTD (maximum tolerated dose) of lenalidomide is defined as the highest dose level at which no more than 1 out of 6 subjects experience a dose-limiting toxicity (DLT) during the first cycle of administration. Dose limiting toxicity is defined as inability to deliver lenalidomide in cycle 1 due to drug related toxicity as outlined below: o any grade 3/4 non-hematologic toxicity (excluding alopecia) o febrile neutropenia o any grade 4 neutropenia lasting for ≥ 7 days o grade 4 thrombocytopenia
    End point type
    Primary
    End point timeframe
    28 days End of cycle 1 of each patient
    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 is provided as this is an one armed, open label, non-comperative study. Two out of 6 patients each in the 10 mg cohort and the 15 mg cohort developed DLTs. Therefore 5 mg lenalidomide was identified as the MTD.
    End point values
    Cohort 5 mg Cohort 10 mg Cohort 15 mg
    Number of subjects analysed
    6
    6
    6
    Units: Patients
        DLT in cycle 1
    0
    2
    2
        No DLT in cycle 1
    6
    4
    4
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All patients having received at least one dose of the study medication were followed for adverse events from treatment start to 28 days after discontinuing study treatment or completion of study.
    Adverse event reporting additional description
    Laboratory test value abnormalities as such were not reported on the AE page of the CRF as adverse events, unless there was an associated clinical condition for which the patient was given treatment or concomitant treatment altered, it was considered to be a serious adverse event, or the patient was permanently discontinued from study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    -

    Serious adverse events
    Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 20 (70.00%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    1
    Vascular disorders
    Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Blastic plasmacytoid dendritic cell neoplasia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    General physical health deterioration
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Cyanosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Rectal tenesmus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Swelling face
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Atypical pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    1 / 2
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    Vascular disorders
    Angiopathy
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gingival bleeding
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Haematochezia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Haematoma
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Haemorrhagic vasculitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Surgical and medical procedures
    Lipoma excision
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal polyp
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    7 / 20 (35.00%)
         occurrences all number
    11
    Injection site erythema
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Mucosal inflammation
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Night sweats
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    4
    Oedema
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    15
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Mental disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Cervix disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ligament sprain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Vaccination complication
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood uric acid increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Chlamydia test positive
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Tricuspid valve disease
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis bacterial
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    5 / 20 (25.00%)
         occurrences all number
    6
    Productive cough
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory distress
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory failure
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    7
    Febrile neutropenia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Leukocytosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Leukopenia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    6
    Lymphopenia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    6 / 20 (30.00%)
         occurrences all number
    8
    Thrombocytopenia
         subjects affected / exposed
    10 / 20 (50.00%)
         occurrences all number
    27
    Nervous system disorders
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dysgeusia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Neuropathy peripheral
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Paraesthesia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Polyneuropathy
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Tremor
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Chorioretinal disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Macular degeneration
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Vertigo
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Abdominal pain upper
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Ascites
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    5 / 20 (25.00%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    9
    Dry mouth
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal hypermotility
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Herpes simplex
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Ileal ulcer
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Oral mucosa haematoma
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Rectal tenesmus
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Renal pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    6
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    3
    Skin and subcutaneous tissue disorders
    Actinic elastosis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Petechiae
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Psoriasis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    5
    Rosacea
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin lesion
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin plaque
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Bursitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    3
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Sciatica
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Sjogren's syndrome
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3
    Folate deficiency
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    3
    Hypokalaemia
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    4
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 20 (20.00%)
         occurrences all number
    10
    Pneumonia
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 20 (10.00%)
         occurrences all number
    2
    Transfusion reaction
         subjects affected / exposed
    1 / 20 (5.00%)
         occurrences all number
    2
    Bronchitis
         subjects affected / exposed
    3 / 20 (15.00%)
         occurrences all number
    3

    More information

    Close Top of page

    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA