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    Clinical Trial Results:
    CD19-targeting 3rd generation CAR T cells for refractory B cell malignancy - a phase I/IIa trial.

    Summary
    EudraCT number
    2013-001393-19
    Trial protocol
    SE  
    Global end of trial date
    31 May 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jun 2018
    First version publication date
    20 Jun 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    003:TCELL
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02132624
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Uppsala university
    Sponsor organisation address
    Dag Hammarskjöldsväg 20, Uppsala, Sweden, 75185
    Public contact
    Angelica Loskog, Uppsala University, Dept of Immunology, Gentetics and Pathology, 46 184715033-, angelica.loskog@igp.uu.se
    Scientific contact
    Angelica Loskog, Uppsala University, Dept of Immunology, Gentetics and Pathology, 46 184715033-, angelica.loskog@igp.uu.se
    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
    20 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the feasibility of a single administration of CAR T cells to patients with disseminated B cell lymphoma or leukemia by studying the tolerance and toxicity.
    Protection of trial subjects
    The main serious risks for patients treated with CAR T cells are cytokine release syndrome, brain edema and risk of infection due to low immunoglobulin level. The patients have been closely monitored and tocilizumab (anti-IL6R) was successfully used to limit cytokine release syndrome. We had no brain edemas in our study. Treating physician was monitoring immunoglobulin levels to enable displacement therapy when needed.
    Background therapy
    In this trial third generation CAR T cells were used to treat adult patients with B cell malignancy (including both NHL and ALL). The CAR construct contained not only two signaling domains (commonly zeta chain and CD28 or 41BB in other clinically used CARs) but three domains. Those are zeta chain of the TcR complex, intracellular CD28 and 41BB. The CAR used was targeted to CD19 expressed on B cells. Patients were pretreated with their standard chemotherapy during weeks of CAR T cell manufacture in an attempt to control tumor growth until CARs were ready to use. The days prior CAR infusion, most patients recieved "preconditioning" with fludarabine and cyclophosphamide (low dose). The patients did not need intensive CAR during preconditioning in this study and it was given as "out patient" treatment.
    Evidence for comparator
    No comparator was used.
    Actual start date of recruitment
    02 Sep 2013
    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
    Sweden: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    9
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Patients were recruited 2014-2016 in Sweden. The trial site was in Uppsala but some patients were referred to by other hospitals.

    Pre-assignment
    Screening details
    Main reason for failing screening was too short expected survival that would result in patients not surviving long enough for the CAR T cells to be manufactured. Three of enrolled patients did not receive CAR T cells for this reason. Too poor blood status compromized ability to manufacture CARs from patient blood in one patient.

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

    Arms
    Arm title
    CAR T cells
    Arm description
    CAR T cell infusion in patients pretreated/preconditioned
    Arm type
    Experimental

    Investigational medicinal product name
    CAR T cells
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    2x10e7 - 2x10e8 cells/m2

    Number of subjects in period 1
    CAR T cells
    Started
    15
    Completed
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    -

    Reporting group values
    overall trial Total
    Number of subjects
    15 15
    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))
    61 (24 to 72) -
    Gender categorical
    Units: Subjects
        Female
    7 7
        Male
    8 8

    End points

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    End points reporting groups
    Reporting group title
    CAR T cells
    Reporting group description
    CAR T cell infusion in patients pretreated/preconditioned

    Primary: Dose limiting toxicity from treatment to end of study participation

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    End point title
    Dose limiting toxicity from treatment to end of study participation [1]
    End point description
    Adverse events leading to decision to reduce CAR T cell dose in the study
    End point type
    Primary
    End point timeframe
    From injection of CAR T cells to end of study participation.
    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: This study did not have any dose limiting toxicities. No statistical calculations were done.
    End point values
    CAR T cells
    Number of subjects analysed
    15
    Units: number of events
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Persistance of CAR T cells

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    End point title
    Persistance of CAR T cells
    End point description
    PCR detection of CAR T cells in blood post treatment confirmed or not confirmed
    End point type
    Secondary
    End point timeframe
    From treatment to maximum 24 months post treatment
    End point values
    CAR T cells
    Number of subjects analysed
    15
    Units: Presence
        number (not applicable)
    15
    No statistical analyses for this end point

    Secondary: Responding patients (at least PR)

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    End point title
    Responding patients (at least PR)
    End point description
    Treatment response (at least partial response; PR) post CAR infusion
    End point type
    Secondary
    End point timeframe
    From treatment to maximum 24 months post treatment
    End point values
    CAR T cells
    Number of subjects analysed
    15
    Units: Number
    6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Enrollment to last visit (maximum 24 months post CAR T cell infusion)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    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
    5 / 15 (33.33%)
         number of deaths (all causes)
    13
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Elevated Lactase dehydrogenase
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Elevated c-reactive protein
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fainting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Cytokine release syndrome
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hypoxia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Weakness in legs
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    CNS disturbance
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Fever
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences causally related to treatment / all
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    Flu like symtom
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skeletal pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Chest wall pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Septicemia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Sore throat
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    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
    15 / 15 (100.00%)
    Vascular disorders
    Ruddiness
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    hypertension diastolic
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Cold like symptoms
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    common cold
         subjects affected / exposed
    6 / 15 (40.00%)
         occurrences all number
    10
    Enlarged abdomen
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Flushing
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    7
    Mucositis
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Pain shoulder blades
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pain lymph node
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    pain in arm
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Sweating
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Swollen fingers
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pain in abdomen
    Additional description: Due to tumor location
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    weight gain
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    pain in legs
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    swollen feet
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    inguinal pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Lethargic
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Reproductive system and breast disorders
    gynecological bleeding
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Fracture
    Additional description: lumbar vertebrae
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin wound
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Investigations
    Elevated ALT
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Elevated bilirubin
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Elevated IL-6
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    Elevated INR
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Hypoalbuminemia
         subjects affected / exposed
    6 / 15 (40.00%)
         occurrences all number
    8
    Hypocalcemia
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    hyponatremia
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Hypokalemia
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Leukopenia
         subjects affected / exposed
    8 / 15 (53.33%)
         occurrences all number
    8
    Neutropenia
         subjects affected / exposed
    8 / 15 (53.33%)
         occurrences all number
    10
    Trombocytopenia
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    6
    Increased calcium
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    3
    Decreased bilirubin
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Decreased TPK
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hypernatraemia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    decreased lymphocytes
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    5
    Elevated ALP
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    3
    Elevated AST
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Decreased creatinine
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Decreased erythrocytes
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Elevated uric acid
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Decreased ALT
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Elevated thrombocytes
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Cardiac disorders
    Fainting symptoms
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    6
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    atrial septal defect
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    11 / 15 (73.33%)
         occurrences all number
    19
    Nose bleeding
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    4
    Pancytopenia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    lymph node bilateral fossa supraclavicula
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Lymph node left axilla
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Lymph node right axilla
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    4
    dry cough
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dyspnea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    shortness of breath
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Shivering
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    balance disturbance
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Genital sensory loss
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hallucination
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Sensory loss
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    4
    Eye disorders
    Diplopia
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    5
    Blisters
    Additional description: tounge
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    4
    diarrhea
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Dry mouth
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Esophageal reflux
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    7 / 15 (46.67%)
         occurrences all number
    11
    Rectal bleeding
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Taste alteration
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    5
    improved digestion
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Stool analysis
    Additional description: yellowish
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    esophageal pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Smelly stool
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hiccups
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Renal and urinary disorders
    Urine retention
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Bruises
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Petechiae arms and abdomen
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Petechiae, hematoma
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Skin rash
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    turgidity
    Additional description: right eye
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    rash maculopapular
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Difficulties to move
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Muscle pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Osteoporosis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    arthrosis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Endocrine disorders
    hyperglycemia
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Metabolism and nutrition disorders
    Loss of apetite
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    anorexia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    Shingles
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Soft tissue infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1

    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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