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    Clinical Trial Results:
    A rollover study to provide continued treatment with eltrombopag

    Summary
    EudraCT number
    2013-001371-20
    Trial protocol
    IE   ES   BE   GR   PL   NL  
    Global end of trial date
    23 Feb 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Dec 2022
    First version publication date
    21 Dec 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    200170
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01957176
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    CETB115A2X01B: Novartis
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    Novartis Campus, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to provide continued treatment with eltrombopag for subjects who were participating in a Novartis-sponsored investigational study with eltrombopag (parent studies 114968/ASPIRE (NCT01440374), PMA112509 (NCT00903422), and TRA105325/EXTEND (NCT00351468), receiving clinical benefit without unacceptable toxicity and to collect long-term safety data.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Oct 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
    Belgium: 1
    Country: Number of subjects enrolled
    China: 4
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Greece: 2
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Korea, Republic of: 1
    Country: Number of subjects enrolled
    Netherlands: 1
    Country: Number of subjects enrolled
    Peru: 2
    Country: Number of subjects enrolled
    Poland: 1
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Tunisia: 6
    Worldwide total number of subjects
    22
    EEA total number of subjects
    8
    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
    12
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    22 subjects were enrolled in 14 centers in 12 countries (Belgium, China, France, Greece, Hong Kong, Ireland, Korea, Republic of., Netherlands, Peru, Poland, Romania, Tunisia).

    Period 1
    Period 1 title
    Overall Study (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 A (MDS/AML adult subjects)
    Arm description
    All subjects in this cohort received eltrombopag (ELT) at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that were used in this cohort were from 50 to 300 mg once daily (OD) for subjects of non-East Asian heritage. The dose ranges for subjects of East Asian heritage (i.e., Japanese, Chinese, Taiwanese, Thai and Korean) were 25 to 150 mg. Dose adjustments (if required) were done depending on each subject’s platelet counts.
    Arm type
    Experimental

    Investigational medicinal product name
    Eltrombopag (ELT)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with the same formulation of eltrombopag that was administered in the parent study. Eltrombopag tablets are white, round film-coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg, and 100 mg of eltrombopag.

    Arm title
    Cohort B (ITP adult subjects)
    Arm description
    All subjects in this cohort received ELT at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that were used in this cohort were from 12.5 to 75 mg. Dose adjustments (if required) were done depending on each subject’s platelet counts.
    Arm type
    Experimental

    Investigational medicinal product name
    Eltrombopag (ELT)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered with the same formulation of eltrombopag that was administered in the parent study. Eltrombopag tablets are white, round film-coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg, and 100 mg of eltrombopag.

    Number of subjects in period 1
    Cohort A (MDS/AML adult subjects) Cohort B (ITP adult subjects)
    Started
    8
    14
    Completed
    3
    13
    Not completed
    5
    1
         Consent withdrawn by subject
    1
    -
         Physician decision
    2
    1
         Adverse event, non-fatal
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A (MDS/AML adult subjects)
    Reporting group description
    All subjects in this cohort received eltrombopag (ELT) at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that were used in this cohort were from 50 to 300 mg once daily (OD) for subjects of non-East Asian heritage. The dose ranges for subjects of East Asian heritage (i.e., Japanese, Chinese, Taiwanese, Thai and Korean) were 25 to 150 mg. Dose adjustments (if required) were done depending on each subject’s platelet counts.

    Reporting group title
    Cohort B (ITP adult subjects)
    Reporting group description
    All subjects in this cohort received ELT at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that were used in this cohort were from 12.5 to 75 mg. Dose adjustments (if required) were done depending on each subject’s platelet counts.

    Reporting group values
    Cohort A (MDS/AML adult subjects) Cohort B (ITP adult subjects) Total
    Number of subjects
    8 14 22
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 9 9
        From 65-84 years
    7 5 12
        85 years and over
    1 0 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    73.8 ( 7.57 ) 59.5 ( 13.18 ) -
    Sex: Female, Male
    Units: Participants
        Female
    3 12 15
        Male
    5 2 7
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaskan Native
    0 2 2
        Asian - East Asian Heritage
    1 5 6
        White - Arabic/North African Heritage
    0 6 6
        White - White/Caucasian/European Heritage
    7 1 8

    End points

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    End points reporting groups
    Reporting group title
    Cohort A (MDS/AML adult subjects)
    Reporting group description
    All subjects in this cohort received eltrombopag (ELT) at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that were used in this cohort were from 50 to 300 mg once daily (OD) for subjects of non-East Asian heritage. The dose ranges for subjects of East Asian heritage (i.e., Japanese, Chinese, Taiwanese, Thai and Korean) were 25 to 150 mg. Dose adjustments (if required) were done depending on each subject’s platelet counts.

    Reporting group title
    Cohort B (ITP adult subjects)
    Reporting group description
    All subjects in this cohort received ELT at the dose that they were receiving at the time of the transition visit, except in the case where the subject required a dose modification. The range of doses of ELT that were used in this cohort were from 12.5 to 75 mg. Dose adjustments (if required) were done depending on each subject’s platelet counts.

    Primary: Number of Participants with Adverse Events (AEs)

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    End point title
    Number of Participants with Adverse Events (AEs) [1]
    End point description
    The distribution of adverse events was done via the analysis of frequencies for Adverse Events (AEs) and Serious Adverse Events (SAEs), through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
    End point type
    Primary
    End point timeframe
    From the time of transition visit until 30 days after last dose of study treatment, assessed up to approximately 100 months.
    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: Only descriptive analysis performed.
    End point values
    Cohort A (MDS/AML adult subjects) Cohort B (ITP adult subjects)
    Number of subjects analysed
    8
    14
    Units: Participants
        Adverse Events (AEs)
    7
    12
        Serious Adverse Events (SAEs)
    6
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of transition visit until 30 days after last dose of study treatment, assessed up to approximately 100 months.
    Adverse event reporting additional description
    Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field “number of deaths resulting from adverse events” all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    MDS/AML Adult
    Reporting group description
    MDS/AML Adult

    Reporting group title
    All Subjects
    Reporting group description
    All Subjects

    Reporting group title
    ITP Adult
    Reporting group description
    ITP Adult

    Serious adverse events
    MDS/AML Adult All Subjects ITP Adult
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 8 (75.00%)
    13 / 22 (59.09%)
    7 / 14 (50.00%)
         number of deaths (all causes)
    3
    5
    2
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Humerus fracture
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    MDS/AML Adult All Subjects ITP Adult
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 8 (87.50%)
    19 / 22 (86.36%)
    12 / 14 (85.71%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    2
    3
    1
    Hot flush
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hypertension
         subjects affected / exposed
    1 / 8 (12.50%)
    5 / 22 (22.73%)
    4 / 14 (28.57%)
         occurrences all number
    1
    6
    5
    Hypertensive crisis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 22 (13.64%)
    2 / 14 (14.29%)
         occurrences all number
    1
    3
    2
    Chest pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Chills
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Discomfort
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    3
    3
    Face oedema
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    Fatigue
         subjects affected / exposed
    2 / 8 (25.00%)
    2 / 22 (9.09%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    0
    Inflammation
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Mucosal haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Oedema peripheral
         subjects affected / exposed
    3 / 8 (37.50%)
    4 / 22 (18.18%)
    1 / 14 (7.14%)
         occurrences all number
    3
    4
    1
    Pyrexia
         subjects affected / exposed
    4 / 8 (50.00%)
    7 / 22 (31.82%)
    3 / 14 (21.43%)
         occurrences all number
    4
    9
    5
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Heavy menstrual bleeding
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    8
    8
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Scrotal oedema
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial irritation
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Dyspnoea exertional
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Pleuritic pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Rales
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Confusional state
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Insomnia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    3
    3
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 22 (18.18%)
    3 / 14 (21.43%)
         occurrences all number
    2
    7
    5
    Apolipoprotein E abnormal
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 22 (18.18%)
    3 / 14 (21.43%)
         occurrences all number
    1
    7
    6
    Blood albumin decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 22 (13.64%)
    3 / 14 (21.43%)
         occurrences all number
    0
    4
    4
    Blood glucose increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Blood pressure increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Blood urea increased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Globulins increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Haematocrit increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Haemoglobin decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    0
    Haemoglobin increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Neutrophil count decreased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Neutrophil count increased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Platelet count increased
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    7
    7
    Protein total increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    Urinary occult blood positive
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Urine ketone body present
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    White blood cell count increased
         subjects affected / exposed
    2 / 8 (25.00%)
    4 / 22 (18.18%)
    2 / 14 (14.29%)
         occurrences all number
    3
    6
    3
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Humerus fracture
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Injury
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Procedural pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Rib fracture
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Scratch
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Vaccination complication
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Nervous system disorders
    Diabetic neuropathy
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Dizziness
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    3
    3
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 22 (27.27%)
    5 / 14 (35.71%)
         occurrences all number
    1
    8
    7
    Lethargy
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Neuralgia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 8 (25.00%)
    4 / 22 (18.18%)
    2 / 14 (14.29%)
         occurrences all number
    2
    7
    5
    Eosinophilia
         subjects affected / exposed
    0 / 8 (0.00%)
    5 / 22 (22.73%)
    5 / 14 (35.71%)
         occurrences all number
    0
    31
    31
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 22 (13.64%)
    3 / 14 (21.43%)
         occurrences all number
    0
    8
    8
    Leukocytosis
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    10
    10
    Lymphadenopathy
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    4
    4
    0
    Monocytosis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Neutropenia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Neutrophilia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Thrombocytopenia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Diabetic retinopathy
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Anal fissure
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Ascites
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Diarrhoea
         subjects affected / exposed
    1 / 8 (12.50%)
    5 / 22 (22.73%)
    4 / 14 (28.57%)
         occurrences all number
    1
    7
    6
    Duodenitis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Epigastric discomfort
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Gingival bleeding
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    Hiatus hernia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Large intestine polyp
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Melaena
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    8
    7
    Nausea
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    Odynophagia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    10
    10
    Rectal haemorrhage
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    Stomatitis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Toothache
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    4
    3
    Vomiting
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Jaundice
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Ocular icterus
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Skin and subcutaneous tissue disorders
    Ecchymosis
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Night sweats
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Petechiae
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    3
    4
    1
    Pruritus
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Purpura
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Rash
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Skin lesion
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    0
    Pollakiuria
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    5
    5
    Proteinuria
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 22 (27.27%)
    5 / 14 (35.71%)
         occurrences all number
    1
    17
    16
    Back pain
         subjects affected / exposed
    1 / 8 (12.50%)
    3 / 22 (13.64%)
    2 / 14 (14.29%)
         occurrences all number
    1
    4
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Muscle spasms
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    2
    2
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    2
    2
    Myalgia
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Neck pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Osteoarthritis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Osteoporosis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Tendon pain
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    4
    4
    COVID-19
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Cellulitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    3
    3
    Ear infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 22 (13.64%)
    3 / 14 (21.43%)
         occurrences all number
    0
    3
    3
    Genital infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Gingivitis
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    2
    2
    Herpes zoster
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Influenza
         subjects affected / exposed
    1 / 8 (12.50%)
    4 / 22 (18.18%)
    3 / 14 (21.43%)
         occurrences all number
    1
    4
    3
    Kidney infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Lip infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    0 / 8 (0.00%)
    2 / 22 (9.09%)
    2 / 14 (14.29%)
         occurrences all number
    0
    11
    11
    Onychomycosis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Oral herpes
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Periodontitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Pneumonia
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    Rhinitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Tooth infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    6
    6
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8 (12.50%)
    6 / 22 (27.27%)
    5 / 14 (35.71%)
         occurrences all number
    1
    10
    9
    Urinary tract infection
         subjects affected / exposed
    0 / 8 (0.00%)
    3 / 22 (13.64%)
    3 / 14 (21.43%)
         occurrences all number
    0
    9
    9
    Vaginal infection
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    3
    2
    Diabetes mellitus
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Gout
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hyperuricaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 8 (12.50%)
    2 / 22 (9.09%)
    1 / 14 (7.14%)
         occurrences all number
    1
    2
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hypokalaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hypomagnesaemia
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 22 (4.55%)
    1 / 14 (7.14%)
         occurrences all number
    0
    1
    1
    Hyponatraemia
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 22 (4.55%)
    0 / 14 (0.00%)
         occurrences all number
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Apr 2016
    The purpose of this amendment was (following the acquisition of SB-497115/eltrombopag from GSK): • To delete or replace references to GSK or its staff with that of Novartis and its authorized agents to align with the change of sponsorship; • Make administrative changes to align with Novartis processes and procedures.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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