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    Clinical Trial Results:
    A RANDOMISED, DOUBLE-BLIND, PARALLEL-GROUP, MULTICENTRE, PHASE II STUDY TO EVALUATE THE SAFETY AND PHARMACOLOGICAL ACTIVITY OF THE COMBINATION OF VANDETANIB (100 OR 300 MG/DAILY OR PLACEBO) WITH FULVESTRANT (LOADING DOSE), IN POSTMENOPAUSAL ADVANCED BREAST CANCER PATIENTS.

    Summary
    EudraCT number
    		 2008-000579-12
    Trial protocol
    		 IT  
    Global end of trial date
    28 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D4200L00009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00752986
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical Dept AstraZeneca
    Sponsor organisation address
    Via Ludovico il Moro, 6/C, Basiglio, Italy, 20080
    Public contact
    Constanza Oliveros, AstraZeneca Lab Italia, +39 02 98014269, constanza.oliveros@astrazeneca.com
    Scientific contact
    Constanza Oliveros, MD, AstraZeneca Lab Italia, +39 02 98011, ClinicalTrialTransparency@ASTRAZENECA.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
    25 Jul 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the event-free survival (EFS) defined as the time from randomisation to progression, death without progression, loss to follow up, whichever occurred first. End-point Efficacy: event-free survival (EFS) The secondary objectives of the study are to assess: • Success rate at 6 months • Objective tumor Response rates (complete response, CR and partial response, PR) according to RECIST criteria (Therasse P et al 2000) • Time To Progression· • Progression Free Survival· • Overall Survival· • Safety and tolerability of vandetanib / Placebo in combination with fulvestrant Efficacy- Safety main objective of Trial
    Protection of trial subjects
    Pain relief medication
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    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)
    23
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 the study was prtematurely terminated with 41 enrolled patients and 39 randomized, out of the 135 scheduled by protocol. A total of 8 serious adverse events have been reported in 6 patients overall. 2 patients had 2 SAEs 41 pts enrolled , 39 randomized. two patients never received the drug.

    Pre-assignment
    Screening details
    		 41 pts enrolled , 39 randomized. two patients never received the drug.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Vandetanib at the dose of 100 mg
    Arm description
    		 vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vandetanib
    Investigational medicinal product code
    Vandetanib
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100mg

    Arm title
    		 Vandetanib at the dose of 300 mg
    Arm description
    		 vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vandetanib
    Investigational medicinal product code
    Vandetanib
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300mg

    Arm title
    		 Placebo to match vandetanib 100 mg and 300 mg
    Arm description
    		 placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match vandetanib 100 mg and 300 mg

    Number of subjects in period 1 [1]
    		Vandetanib at the dose of 100 mg Vandetanib at the dose of 300 mg Placebo to match vandetanib 100 mg and 300 mg
    Started
    16
    12
    11
    Completed
    11
    11
    9
    Not completed
    5
    1
    2
         Consent withdrawn by subject
    2
    1
    2
         Protocol deviation
    3
    -
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The total number of patients enrolled is equal to 41. Only 39 patients received the treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vandetanib at the dose of 100 mg
    Reporting group description
    		 vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

    Reporting group title
    Vandetanib at the dose of 300 mg
    Reporting group description
    		 vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

    Reporting group title
    Placebo to match vandetanib 100 mg and 300 mg
    Reporting group description
    		 placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).

    Reporting group values
    		 Vandetanib at the dose of 100 mg Vandetanib at the dose of 300 mg Placebo to match vandetanib 100 mg and 300 mg Total
    Number of subjects
    		 16 12 11 39
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 16 12 11 39
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    		 63.6 (44 to 78) 59.8 (48 to 79) 59.6 (43 to 74) -
    Gender, Male/Female
    Female
    Units: Partecipants
        Female
    		 16 12 11 39

    End points

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    End points reporting groups
    Reporting group title
    Vandetanib at the dose of 100 mg
    Reporting group description
    		 vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

    Reporting group title
    Vandetanib at the dose of 300 mg
    Reporting group description
    		 vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

    Reporting group title
    Placebo to match vandetanib 100 mg and 300 mg
    Reporting group description
    		 placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).

    Primary: Event Free Survival

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    End point title
    		 Event Free Survival [1]
    End point description
    Success rate (patients without progression and still on treatment at 24 weeks
    End point type
    Primary
    End point timeframe
    Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.
    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 of data was performed.
    End point values
    		 Vandetanib at the dose of 100 mg Vandetanib at the dose of 300 mg Placebo to match vandetanib 100 mg and 300 mg
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    Units: partecipants
        number (not applicable)
    Notes
    [2] - No statistical analisys was performed
    [3] - No statistical analisys was performed
    [4] - No statistical analisys was performed
    No statistical analyses for this end point

    Secondary: TTPl, PFS, CR+PR, disease control(CR+PR+SD),DOR

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    End point title
    		 TTPl, PFS, CR+PR, disease control(CR+PR+SD),DOR
    End point description
    End point type
    Secondary
    End point timeframe
    Restaging (RECIST) is carried out at screening and every 3 months during the study until 1 year and than every 6 months until objective disease progression.
    End point values
    		 Vandetanib at the dose of 100 mg Vandetanib at the dose of 300 mg Placebo to match vandetanib 100 mg and 300 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    0 [7]
    Units: partecipants
        number (not applicable)
    Notes
    [5] - no statistical analisys was made
    [6] - no statistical analisys was made
    [7] - no statistical analisys was made
    No statistical analyses for this end point

    Secondary: Overall survival

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    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Assessments for survival must be made at the 60 day follow-up visit and then every 3 months, unless the patient withdraws consent.
    End point values
    		 Vandetanib at the dose of 100 mg Vandetanib at the dose of 300 mg Placebo to match vandetanib 100 mg and 300 mg
    Number of subjects analysed
    0 [8]
    0 [9]
    0 [10]
    Units: partecipants
        number (not applicable)
    Notes
    [8] - no statistical analisys was made
    [9] - no statistical analisys was made
    [10] - no statistical analisys was made
    No statistical analyses for this end point

    Secondary: AEs,lab,vital sign and ECG changes

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    End point title
    		 AEs,lab,vital sign and ECG changes
    End point description
    End point type
    Secondary
    End point timeframe
    Continuous assessment of safety.
    End point values
    		 Vandetanib at the dose of 100 mg Vandetanib at the dose of 300 mg Placebo to match vandetanib 100 mg and 300 mg
    Number of subjects analysed
    0 [11]
    0 [12]
    0 [13]
    Units: partecipants
        number (not applicable)
    Notes
    [11] - no statistical analisys was made
    [12] - no statistical analisys was made
    [13] - no statistical analisys was made
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    ongoing basis as per law
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Vandetanib at the dose of 100 mg
    Reporting group description
    		 vandetanib at the dose of 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

    Reporting group title
    Placebo to match vandetanib 100 mg and 300 mg
    Reporting group description
    		 placebo to match vandetanib 100 mg orally once-daily plus placebo to match vandetanib 300 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3).

    Reporting group title
    Vandetanib at the dose of 300 mg
    Reporting group description
    		 vandetanib at the dose of 300 mg orally once-daily plus placebo to match vandetanib 100 mg orally once-daily plus fulvestrant LD (500 mg im. at day 1 and 250 mg at day 14, 28 and thereafter every 28th day +/- 3)

    Serious adverse events
    		 Vandetanib at the dose of 100 mg Placebo to match vandetanib 100 mg and 300 mg Vandetanib at the dose of 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 16 (18.75%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    severe arthralgia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    gastroenteritis.
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    grade 3 diarrhoea
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    grade 3 erythema
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    diabetes complication
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Musculoskeletal and connective tissue disorders
    right iliac fracture
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Vandetanib at the dose of 100 mg Placebo to match vandetanib 100 mg and 300 mg Vandetanib at the dose of 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 16 (75.00%)
    6 / 11 (54.55%)
    11 / 12 (91.67%)
    General disorders and administration site conditions
    RECTAL BLEEDING
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    HEMORRHOIDS
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    TOOTH ACHE
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    NAUSEA
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 11 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    2
    0
    3
    VOMITING
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    2
    INSOMNIA
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    3 / 12 (25.00%)
         occurrences all number
    0
    0
    3
    HEADACHE
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    2
    ANOREXIA
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    ASTHENIA
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    2
    0
    2
    FEVER
         subjects affected / exposed
    2 / 16 (12.50%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    2
    0
    2
    ONYCHOPATY
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    WEIGHT LOSS
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    LOSS OF APPETITE
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    SWEATING
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    ARTHRALGIA
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    FATIGUE
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    THORACIC PAIN
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    PAIN RIGHT THORAX
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    BRONCHITIS
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    ANXIETY
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    ANXIOUS-DEPRESSIVE SYNDROME
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Cardiac disorders
    HYPERTENSION
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    3
    0
    4
    TACHICARDY
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    FLUSHING
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    NEUROPATHY (ARMS)
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    AST ELEVATION
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    ANAEMIA
         subjects affected / exposed
    1 / 16 (6.25%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    3
    1
    0
    NEUTROPENIA
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    LEUKOPENIA
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    HYPERCALCEMIA
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    HYPERTRANSAMINASEMIA
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    2 / 12 (16.67%)
         occurrences all number
    0
    1
    5
    PIASTRINOPENIA
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    3
    TRANSAMINASE INCREASE
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERPOTASSEMIA
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    DIZZINESS
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    VERTIGO
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    LEFT EYE PAIN
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    EYE ANGIOEDEMA
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    RIGHT HYPOCHONDRIUM PAIN
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    DIARRHEA
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 11 (0.00%)
    7 / 12 (58.33%)
         occurrences all number
    3
    0
    14
    Hepatobiliary disorders
    HEPATIC TOXICITY
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    RASH
         subjects affected / exposed
    3 / 16 (18.75%)
    0 / 11 (0.00%)
    6 / 12 (50.00%)
         occurrences all number
    6
    0
    11
    HYPERPIGMENTATION
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    1
    0
    1
    ERYTHEMA
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    2 / 12 (16.67%)
         occurrences all number
    1
    0
    5
    SCALP ERITHEMA
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    PROTEINURIA
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    CYSTITIS
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMORRHAGIC CYSTITIS
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    BONE PAIN
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 11 (9.09%)
    3 / 12 (25.00%)
         occurrences all number
    0
    1
    4
    JOINT PAIN
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    RIB FRACTURE
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    LUMBAR PAIN
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    MUSCOLOSKELETRICAL PAIN
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    MUCOSITIS
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    2
    STOMATITIS
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 11 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    1
    UMBILICAL MYCOSES
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 11 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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

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