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    Clinical Trial Results:
    Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies: a Randomized, Double Blind, Phase III Study versus Allopurinol

    Summary
    EudraCT number
    		 2012-000776-42
    Trial protocol
    		 DE   ES   CZ   HU   IT   PL  
    Global end of trial date
    11 Oct 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Nov 2018
    First version publication date
    04 Nov 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FLO-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01724528
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Menarini Ricerche S.p.A
    Sponsor organisation address
    Via Sette Santi 1, Florence, Italy, 50131
    Public contact
    Direzione Ricerca Clinica, Menarini Ricerche S.p.A, 0039 055 5680 9933, ACapriati@menarini-ricerche.it
    Scientific contact
    Direzione Ricerca Clinica, Menarini Ricerche S.p.A, 0039 055 5680 9933, ACapriati@menarini-ricerche.it
    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
    28 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of febuxostat with allopurinol, in terms of serum uric acid (sUA) level control and preservation of renal function after seven days of treatment (Day 8) starting from 2 days prior chemotherapy (Day 1).
    Protection of trial subjects
    In order to minimize patients’ discomfort and avoid unnecessary blood sampling, the protocol sections dealing with the description of the study procedures to be done at Screening were amended to specify that safety lab tests, urinalysis or 12 lead ECG at Screening Visit not needed to be done if they have been performed in the preceding 24 hours at investigative site for the standard care of the patients (Amendment N.1 dated 15 February 2013).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2012
    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
    Poland: 10
    Country: Number of subjects enrolled
    Spain: 48
    Country: Number of subjects enrolled
    Czech Republic: 4
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Hungary: 54
    Country: Number of subjects enrolled
    Italy: 32
    Country: Number of subjects enrolled
    Brazil: 1
    Country: Number of subjects enrolled
    Croatia: 9
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Russian Federation: 82
    Country: Number of subjects enrolled
    Serbia: 17
    Country: Number of subjects enrolled
    Ukraine: 53
    Worldwide total number of subjects
    346
    EEA total number of subjects
    193
    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)
    230
    From 65 to 84 years
    113
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 First patient in (screening) 01 Oct 2012, last patient out 11 Oct 2013. At 79 sites across 11 European countries (Croatia, Czech Republic, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain and Ukraine) and Brazil

    Pre-assignment
    Screening details
    		 Subjects complying with inclusion/exclusion criteria were to be randomised to receive (blinded) standard, low or high dose of study treatment as per investigator’s assessment (mainly based on renal function). Randomization was balanced by TLS risk and serum uric acid levels (≤ or > 7.5 mg/dL)

    Period 1
    Period 1 title
    Randomization/Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    As the size and the shape of the Allopurinol 100 mg and Febuxostat 120 mg tablets differ as well as the posologic scheme of Allopurinol high dosage, double blind condition were secured by encapsulation of treatment tablets. Differences in weight were compensated by adequate filling material, so that capsules match in weight and appearance.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Febuxostat
    Arm description
    		 Febuxostat for 7-9 days. Febuxostat: standard dose PO (per os) from day 1 to day 7 (can be continued up to day 9 at inverstigator's discretion)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Febuxostat
    Investigational medicinal product code
    Other name
    Adenuric
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    120 mg/day

    Arm title
    		 Allopurinol
    Arm description
    		 Allopurinol for 7-9 days Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from day 1 to day 7 (can be continued up to day 9 at investigator's discretion).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Allopurinol
    Investigational medicinal product code
    Other name
    Zyloric
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg/day (standard dose), 300 mg b.i.d./day (high dose), 200 mg/day (low dose)

    Number of subjects in period 1
    		Febuxostat Allopurinol
    Started
    173
    173
    Completed
    169
    170
    Not completed
    4
    3
         Adverse event, serious fatal
    3
    -
         Consent withdrawn by subject
    -
    2
         Patient refused to attend last visit
    1
    -
         Protocol deviation
    -
    1
    Period 2
    Period 2 title
    End of study visit
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Treatment blinding was kept for the entire study duration up to the closure of database performed after last patient last visit.

    Arms
    Arm title
    		 Either Febuxostat or Allopurinol
    Arm description
    		 Final safety Follow up/End of Study Visit performed two weeks after after the randomization.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Either Febuxostat or Allopurinol
    Started
    339
    Completed
    339

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Febuxostat
    Reporting group description
    		 Febuxostat for 7-9 days. Febuxostat: standard dose PO (per os) from day 1 to day 7 (can be continued up to day 9 at inverstigator's discretion)

    Reporting group title
    Allopurinol
    Reporting group description
    		 Allopurinol for 7-9 days Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from day 1 to day 7 (can be continued up to day 9 at investigator's discretion).

    Reporting group values
    		 Febuxostat Allopurinol Total
    Number of subjects
    		 173 173 346
    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)
    		 112 118 230
        From 65-84 years
    		 60 53 113
        85 years and over
    		 1 2 3
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 58.5 ± 14.26 58.3 ± 13.26 -
    Gender categorical
    Units: Subjects
        Female
    		 65 67 132
        Male
    		 108 106 214
    serum uric acid (sUA)
    Units: Subjects
        < or = 7.5 mg/dL
    		 151 152 303
        > 7.5 mg/dL
    		 22 21 43
    TLS risk
    Units: Subjects
        Intermediate
    		 143 141 284
        High
    		 30 32 62
    Type of Hematologic Malignancy
    Units: Subjects
        Acute leukemia
    		 34 25 59
        Chronic lymphocytic leukemia
    		 80 94 174
        Lymphoma
    		 59 54 113

    End points

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    End points reporting groups
    Reporting group title
    Febuxostat
    Reporting group description
    		 Febuxostat for 7-9 days. Febuxostat: standard dose PO (per os) from day 1 to day 7 (can be continued up to day 9 at inverstigator's discretion)

    Reporting group title
    Allopurinol
    Reporting group description
    		 Allopurinol for 7-9 days Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from day 1 to day 7 (can be continued up to day 9 at investigator's discretion).
    Reporting group title
    Either Febuxostat or Allopurinol
    Reporting group description
    		 Final safety Follow up/End of Study Visit performed two weeks after after the randomization.

    Primary: Serum Uric Acid (sUA) Level Control

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    End point title
    		 Serum Uric Acid (sUA) Level Control
    End point description
    Area under the curve of sUA from baseline (Day 1) to the evaluation visit (Day 8)
    End point type
    Primary
    End point timeframe
    8 days
    End point values
    		 Febuxostat Allopurinol
    Number of subjects analysed
    172
    172
    Units: Mg x hour/dL
        arithmetic mean (standard deviation)
    514 ± 225.71
    708.0 ± 234.42
    Statistical analysis title
    		 Superior test
    Comparison groups
    Febuxostat v Allopurinol
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Confidence interval

    Primary: Preservation of Renal Function

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    End point title
    		 Preservation of Renal Function
    End point description
    Change in serum creatinine level from baseline (Day 1) to the evaluation visit (Day 8)
    End point type
    Primary
    End point timeframe
    8 days
    End point values
    		 Febuxostat Allopurinol
    Number of subjects analysed
    173
    171
    Units: mg/dl
        arithmetic mean (standard deviation)
    -0.03 ± 0.352
    -0.05 ± 0.171
    Statistical analysis title
    		 Superior test
    Comparison groups
    Febuxostat v Allopurinol
    Number of subjects included in analysis
    344
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0903
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Treatment Responder Rate

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    End point title
    		 Treatment Responder Rate
    End point description
    Assessment of treatment responder rate, where treatment response is defined as the maintenance of sUA ≤ 7.5 mg/dL from Day 3 to Day 8
    End point type
    Secondary
    End point timeframe
    6 days
    End point values
    		 Febuxostat Allopurinol
    Number of subjects analysed
    173
    173
    Units: subjects
    3
    7
    Statistical analysis title
    		 Superior test
    Comparison groups
    Febuxostat v Allopurinol
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1993
    Method
    		 Wilson's confidence interval
    Confidence interval

    Secondary: Assessment of Laboratory Tumor Lysis Syndrome (LTLS)

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    End point title
    		 Assessment of Laboratory Tumor Lysis Syndrome (LTLS)
    End point description
    Assessment of LTLS, from Day 3 to Day 8. According to Cairo-Bishop definition LTLS is defined by the presence of 2 or more laboratory abnormalities including: a 25% increase or levels above normal for serum uric acid, potassium, and phosphate or a 25% decrease or levels below normal for calcium.
    End point type
    Secondary
    End point timeframe
    6 days
    End point values
    		 Febuxostat Allopurinol
    Number of subjects analysed
    173
    173
    Units: subjects
    14
    16
    Statistical analysis title
    		 Superior test
    Comparison groups
    Allopurinol v Febuxostat
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8488
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Assessment of Clinical Tumor Lysis Syndrome (CTLS)

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    End point title
    		 Assessment of Clinical Tumor Lysis Syndrome (CTLS)
    End point description
    Assessment of CTLS, from Day 3 to Day 8. According to Cairo-Bishop definition, CTLS is defined by the presence of LTLS in addition to 1 or more of the following significant clinical complications: renal insufficiency, cardiac arrhythmias, sudden death and seizures. The grade of CTLS is defined by the maximal grade of the clinical manifestation
    End point type
    Secondary
    End point timeframe
    6 days
    End point values
    		 Febuxostat Allopurinol
    Number of subjects analysed
    173
    173
    Units: subjects
    3
    2
    Statistical analysis title
    		 Superior test
    Comparison groups
    Febuxostat v Allopurinol
    Number of subjects included in analysis
    346
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    14 ± 2 days
    Adverse event reporting additional description
    Analysed for the Safety Population (all patients who received the study drug)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Febuxostat
    Reporting group description
    		 Febuxostat for 7-9 days. Febuxostat: standard dose PO (per os) from day 1 to day 7 (can be continued up to day 9 at inverstigator's discretion)

    Reporting group title
    Allopurinol
    Reporting group description
    		 Allopurinol for 7-9 days Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from day 1 to day 7 (can be continued up to day 9 at investigator's discretion).

    Serious adverse events
    		 Febuxostat Allopurinol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    21 / 173 (12.14%)
    6 / 173 (3.47%)
         number of deaths (all causes)
    6
    0
         number of deaths resulting from adverse events
    6
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 173 (0.58%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    2 / 173 (1.16%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 173 (1.16%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 173 (1.73%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 173 (1.16%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 173 (0.58%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 173 (2.89%)
    2 / 173 (1.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 173 (1.73%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 173 (0.00%)
    1 / 173 (0.58%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 173 (0.58%)
    0 / 173 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Febuxostat Allopurinol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 173 (67.05%)
    112 / 173 (64.74%)
    Investigations
    Platelet count decreased
         subjects affected / exposed
    9 / 173 (5.20%)
    6 / 173 (3.47%)
         occurrences all number
    9
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 173 (7.51%)
    5 / 173 (2.89%)
         occurrences all number
    14
    5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    38 / 173 (21.97%)
    25 / 173 (14.45%)
         occurrences all number
    48
    31
    Leukopenia
         subjects affected / exposed
    25 / 173 (14.45%)
    27 / 173 (15.61%)
         occurrences all number
    26
    27
    Neutropenia
         subjects affected / exposed
    30 / 173 (17.34%)
    40 / 173 (23.12%)
         occurrences all number
    32
    42
    Thrombocytopenia
         subjects affected / exposed
    25 / 173 (14.45%)
    19 / 173 (10.98%)
         occurrences all number
    28
    20
    General disorders and administration site conditions
    Mucosal inflammation
         subjects affected / exposed
    11 / 173 (6.36%)
    3 / 173 (1.73%)
         occurrences all number
    11
    3
    Pyrexia
         subjects affected / exposed
    23 / 173 (13.29%)
    18 / 173 (10.40%)
         occurrences all number
    25
    21
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    14 / 173 (8.09%)
    11 / 173 (6.36%)
         occurrences all number
    16
    12
    Diarrhoea
         subjects affected / exposed
    16 / 173 (9.25%)
    11 / 173 (6.36%)
         occurrences all number
    21
    13
    Nausea
         subjects affected / exposed
    22 / 173 (12.72%)
    21 / 173 (12.14%)
         occurrences all number
    25
    23
    Vomiting
         subjects affected / exposed
    10 / 173 (5.78%)
    12 / 173 (6.94%)
         occurrences all number
    11
    12
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    6 / 173 (3.47%)
    9 / 173 (5.20%)
         occurrences all number
    7
    10
    Hyperphosphataemia
         subjects affected / exposed
    9 / 173 (5.20%)
    4 / 173 (2.31%)
         occurrences all number
    9
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Feb 2013
    Amendment No.1 specifically deals with the following changes: 1. In order to minimize patients’ discomfort and avoid unnecessary blood sampling, the protocol sections dealing with the description of the study procedures to be done at Screening are amended to specify that safety lab tests, urinalysis or 12 lead ECG at Screening Visit do not need to be done if they have been performed in the preceding 24 hours at investigative site for the standard care of the patients. 2. In order to clarify the exclusion criterion relative to patients with diagnosis of ischemic heart disease or congestive heart failure, the protocol sections dealing with the exclusion criteria are amended to specify that only patients with uncontrolled ischemic heart disease or congestive heart failure cannot participate to the study. 3. In order to include the new EU SMPCs of ADENURIC® 120 MG film-coated tablets (20 December 2012) and minor clarifications and administrative changes.

    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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