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    Clinical Trial Results:
    Post Marketing Surveillance Study to Observe the Safety and Efficacy of Voriconazole Intavenous Infusion

    Summary
    EudraCT number
    2017-000197-11
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    15 May 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    08 Jun 2017
    First version publication date
    08 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    A1501067
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01073618
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, 110017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800 718 1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Oct 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 May 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to determine the efficacy and safety of Voriconazole, 200 mg intravenous infusion (IV).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Apr 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Korea, Republic of: 692
    Worldwide total number of subjects
    692
    EEA total number of subjects
    0
    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)
    10
    Children (2-11 years)
    45
    Adolescents (12-17 years)
    42
    Adults (18-64 years)
    500
    From 65 to 84 years
    95
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 692 subjects were enrolled at multiple centers in Republic of Korea in this study. The study was conducted from 11-Apr-2006 to 19-Oct-2009.

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

    Arms
    Arm title
    Voriconazole
    Arm description
    Subjects aged greater than (>) 12 years with invasive aspergillosis received Voriconazole intravenously at a loading dose of 6 milligrams per kilogram (mg/kg), every 12 hours for the first 24 hours, followed by the maintenance dose of 4 mg/kg intravenously, twice daily up to 2 weeks. Subjects aged >12 years with invasive candidemia received Voriconazole intravenously at a loading dose of 6 mg/kg intravenously, every 12 hours for the first 24 hours, followed by the maintenance dose of Voriconazole 3 to 4 mg/kg intravenously, twice daily up to 2 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Voriconazole 6 mg/kg
    Investigational medicinal product code
    Voriconazole
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received loading dose of Voriconazole 6 mg/kg intravenously twice daily for the first 24 hours up to 2 weeks.

    Investigational medicinal product name
    Voriconazole 4 mg/kg
    Investigational medicinal product code
    Voriconazole
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received maintenance dose of Voriconazole 4 mg/kg intravenously twice daily up to 2 weeks.

    Number of subjects in period 1
    Voriconazole
    Started
    692
    Completed
    385
    Not completed
    307
         Death
             208
         Unspecified
             80
         Adverse Event
             19

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Voriconazole
    Reporting group description
    Subjects aged greater than (>) 12 years with invasive aspergillosis received Voriconazole intravenously at a loading dose of 6 milligrams per kilogram (mg/kg), every 12 hours for the first 24 hours, followed by the maintenance dose of 4 mg/kg intravenously, twice daily up to 2 weeks. Subjects aged >12 years with invasive candidemia received Voriconazole intravenously at a loading dose of 6 mg/kg intravenously, every 12 hours for the first 24 hours, followed by the maintenance dose of Voriconazole 3 to 4 mg/kg intravenously, twice daily up to 2 weeks.

    Reporting group values
    Voriconazole Total
    Number of subjects
    692 692
    Age Categorical
    Units: Subjects
        <18 years
    97 97
        Between 18 and 44 years
    218 218
        Between 45 and 64 years
    282 282
        >=65 years
    95 95
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.7 ± 19.7 -
    Gender, Male/Female
    Units: Subjects
        Female
    275 275
        Male
    417 417

    End points

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    End points reporting groups
    Reporting group title
    Voriconazole
    Reporting group description
    Subjects aged greater than (>) 12 years with invasive aspergillosis received Voriconazole intravenously at a loading dose of 6 milligrams per kilogram (mg/kg), every 12 hours for the first 24 hours, followed by the maintenance dose of 4 mg/kg intravenously, twice daily up to 2 weeks. Subjects aged >12 years with invasive candidemia received Voriconazole intravenously at a loading dose of 6 mg/kg intravenously, every 12 hours for the first 24 hours, followed by the maintenance dose of Voriconazole 3 to 4 mg/kg intravenously, twice daily up to 2 weeks.

    Primary: Percentage of Subjects With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable

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    End point title
    Percentage of Subjects With Categorical Clinical Response: Cure, Improvement, Failure, or Unevaluable [1]
    End point description
    Clinical response was defined as: Cure = resolution of all baseline signs and symptoms of fungal infection(s); Improvement = lessening of baseline signs and symptoms or absence of one or more, but not all baseline findings; Failure = no improvement or deterioration of baseline condition; Unevaluable = Incomplete therapy (efficacy could not be evaluated or discontinuation was not followed up). Intent to treat (ITT) population included subjects who received study drug for the approved indication and had been evaluated for related parameters at least once.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 2 years
    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 was planned to be analyzed in this endpoint
    End point values
    Voriconazole
    Number of subjects analysed
    692
    Units: percentage of subjects
    number (not applicable)
        Cure
    12.72
        Improvement
    41.47
        Failure
    17.92
        Unevaluable
    27.89
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not evaluable

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    End point title
    Percentage of Subjects With Cultivated Strain Mycological Response: Eradication, Persistence, Superinfection, or Not evaluable
    End point description
    Mycological response was defined as: Eradication = absence of signs and symptoms of fungal infection; Persistence = (no eradication) presence of fungal infection; Superinfection = existence of different strains from strains separated prior to study medication; Not evaluable = a follow-up mycological cultivation is not performed. ITT population included subjects who received study drug for the approved indication and had been evaluated for related parameters at least once. Here, 'N' (Number of subjects analyzed) signifies those subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) up to 2 years
    End point values
    Voriconazole
    Number of subjects analysed
    159
    Units: percentage of subjects
    number (not applicable)
        Eradication
    64.78
        Persistence
    27.67
        Superinfection
    3.77
        Not evaluable
    3.77
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 28 days after last dose of study drug
    Adverse event reporting additional description
    The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Voriconazole
    Reporting group description
    Subjects aged >12 years with invasive aspergillosis received Voriconazole intravenously at a loading dose of 6 mg/kg, every 12 hours for the first 24 hours, followed by the maintenance dose of 4 mg/kg intravenously, twice daily up to 2 weeks. Subjects aged >12 years with invasive candidemia received Voriconazole intravenously at a loading dose of 6 mg/kg intravenously, every 12 hours for the first 24 hours, followed by the maintenance dose of Voriconazole 3 to 4 mg/kg intravenously, twice daily up to 2 weeks.

    Serious adverse events
    Voriconazole
    Total subjects affected by serious adverse events
         subjects affected / exposed
    239 / 692 (34.54%)
         number of deaths (all causes)
    220
         number of deaths resulting from adverse events
    Vascular disorders
    Hypotension
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Shock
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Hypopharyngeal cancer
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 7
    Leukaemia
         subjects affected / exposed
    18 / 692 (2.60%)
         occurrences causally related to treatment / all
    0 / 18
         deaths causally related to treatment / all
    0 / 18
    Leukaemia recurrent
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Leukaemic infiltration
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Multiple myeloma
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Rectal cancer
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Immune system disorders
    Acute graft versus host disease in intestine
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Acute graft versus host disease in skin
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Brain death
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Condition aggravated
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Disease progression
         subjects affected / exposed
    14 / 692 (2.02%)
         occurrences causally related to treatment / all
    3 / 14
         deaths causally related to treatment / all
    3 / 14
    General physical health deterioration
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Pyrexia
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    17 / 692 (2.46%)
         occurrences causally related to treatment / all
    0 / 17
         deaths causally related to treatment / all
    0 / 14
    Injury, poisoning and procedural complications
    Collapse of lung
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chemical peritonitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Acoustic stimulation tests
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood creatinine
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus test positive
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Atrial fibrillation
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Cardiac failure
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Pericarditis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
         subjects affected / exposed
    12 / 692 (1.73%)
         occurrences causally related to treatment / all
    1 / 12
         deaths causally related to treatment / all
    1 / 9
    Acute respiratory failure
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bronchopulmonary dysplasia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hydropneumothorax
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    9 / 692 (1.30%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    Haemoptysis
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypoxia
         subjects affected / exposed
    9 / 692 (1.30%)
         occurrences causally related to treatment / all
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    Pneumothorax
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Pulmonary oedema
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    Respiratory arrest
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Respiratory failure
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences causally related to treatment / all
    0 / 7
         deaths causally related to treatment / all
    0 / 7
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    5 / 692 (0.72%)
         occurrences causally related to treatment / all
    1 / 5
         deaths causally related to treatment / all
    1 / 2
    Thrombotic microangiopathy
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 3
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Nervous system disorders
    Cerebral infarction
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Convulsion
         subjects affected / exposed
    8 / 692 (1.16%)
         occurrences causally related to treatment / all
    2 / 8
         deaths causally related to treatment / all
    2 / 2
    Intracranial pressure increased
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Mental impairment
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenic colitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic failure
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Hepatorenal failure
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Hepatic function abnormal
         subjects affected / exposed
    4 / 692 (0.58%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hepatosplenomegaly
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 2
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    Nephropathy toxic
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Renal failure acute
         subjects affected / exposed
    9 / 692 (1.30%)
         occurrences causally related to treatment / all
    2 / 9
         deaths causally related to treatment / all
    2 / 4
    Renal failure chronic
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Renal impairment
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Euthyroid sick syndrome
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Hypernatraemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    3 / 692 (0.43%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    1 / 2
    Hyperkalaemia
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Brain abscess
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Anal abscess
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspergillosis
         subjects affected / exposed
    6 / 692 (0.87%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 5
    Cellulitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Fungal infection
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 2
    Liver abscess
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    57 / 692 (8.24%)
         occurrences causally related to treatment / all
    2 / 57
         deaths causally related to treatment / all
    2 / 53
    Pneumonia fungal
         subjects affected / exposed
    2 / 692 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Pneumonia primary atypical
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Sepsis
         subjects affected / exposed
    29 / 692 (4.19%)
         occurrences causally related to treatment / all
    2 / 29
         deaths causally related to treatment / all
    2 / 25
    Septic shock
         subjects affected / exposed
    44 / 692 (6.36%)
         occurrences causally related to treatment / all
    2 / 44
         deaths causally related to treatment / all
    0 / 35
    Enterococcal infection
         subjects affected / exposed
    1 / 692 (0.14%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Voriconazole
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 692 (13.58%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences all number
    7
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    14 / 692 (2.02%)
         occurrences all number
    14
    Transaminases increased
         subjects affected / exposed
    10 / 692 (1.45%)
         occurrences all number
    10
    Blood creatinine increased
         subjects affected / exposed
    10 / 692 (1.45%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 692 (1.16%)
         occurrences all number
    8
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    12 / 692 (1.73%)
         occurrences all number
    12
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    9 / 692 (1.30%)
         occurrences all number
    9
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    14 / 692 (2.02%)
         occurrences all number
    14
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    7 / 692 (1.01%)
         occurrences all number
    7
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    10 / 692 (1.45%)
         occurrences all number
    10

    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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