Vfend Special Investigation For Prophylaxis

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT02674685
Collaborator
(none)
241
39.7

Study Details

Study Description

Brief Summary

Examine the safety and effectiveness of Vfend [voriconazole] for prophylaxix use under general clinical practices.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    241 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    VFEND SPECIAL INVESTIGATION FOR PROPHYLAXIS
    Actual Study Start Date :
    Mar 11, 2016
    Actual Primary Completion Date :
    Jul 3, 2019
    Actual Study Completion Date :
    Jul 3, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Drug Reactions [Maximum 3 years]

      An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.

    Secondary Outcome Measures

    1. Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions) [Maximum 3 years]

      An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician.

    2. Proportion of Participants With Adverse Drug Reactions by Age [Maximum 3 years]

      An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by age (<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.

    3. Proportion of Participants With Adverse Drug Reactions by Reason for Use [Maximum 3 years]

      An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by reason for use to assess whether it was a risk factor for the occurrence of ADRs.

    4. Proportion of Participants With Adverse Drug Reactions by Long-term Use [Maximum 3 years]

      An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by long-term use to assess whether it was a risk factor for the occurrence of ADRs.

    5. Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) [Maximum 3 years]

      IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.

    6. Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age [Maximum 3 years]

      IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.

    7. Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use [Maximum 3 years]

      IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.

    8. Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) [Maximum 3 years]

      Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.

    9. Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age [Maximum 3 years]

      Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.

    10. Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use [Maximum 3 years]

      Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients undergoing HSCT (Hematopoietic Stem Cell Transplantation).
    Exclusion Criteria:
    • Patients who have been previously enrolled in this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02674685
    Other Study ID Numbers:
    • A1501106
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Period Title: Overall Study
    STARTED 237
    COMPLETED 233
    NOT COMPLETED 4

    Baseline Characteristics

    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Overall Participants 233
    Age, Customized (Number) [Number]
    <15 years
    79
    33.9%
    ≥15 and <65 years
    128
    54.9%
    ≥65 years
    26
    11.2%
    Sex: Female, Male (Count of Participants)
    Female
    96
    41.2%
    Male
    137
    58.8%
    Race and Ethnicity Not Collected (Count of Participants)
    Reason for Use (Number) [Number]
    Primary prophylaxis
    216
    92.7%
    Secondary prophylaxis
    16
    6.9%
    Others
    1
    0.4%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants With Adverse Drug Reactions
    Description An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to VFEND was assessed by the physician.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 233
    ADR
    62
    26.6%
    Serious ADR
    5
    2.1%
    2. Secondary Outcome
    Title Number of Participants With Adverse Drug Reactions Not Expected From the Approved Local Product Document (Unknown Adverse Drug Reactions)
    Description An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to VFEND was assessed by the physician.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 233
    Number [Participants]
    6
    2.6%
    3. Secondary Outcome
    Title Proportion of Participants With Adverse Drug Reactions by Age
    Description An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by age (<15 years, ≥15 years) to assess whether it was a risk factor for the occurrence of ADRs.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 233
    <15 years
    20.25
    8.7%
    ≥15 years
    29.87
    12.8%
    4. Secondary Outcome
    Title Proportion of Participants With Adverse Drug Reactions by Reason for Use
    Description An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by reason for use to assess whether it was a risk factor for the occurrence of ADRs.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 233
    Primary prophylaxis
    26.39
    11.3%
    Secondary prophylaxis
    31.25
    13.4%
    Others
    0.00
    0%
    5. Secondary Outcome
    Title Proportion of Participants With Adverse Drug Reactions by Long-term Use
    Description An adverse drug reaction (ADR) was any untoward medical occurrence attributed to VFEND in a participant who received VFEND. Relatedness to VFEND was assessed by the physician. Participants with ADRs were counted by long-term use to assess whether it was a risk factor for the occurrence of ADRs.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The safety analysis set comprised of participants who satisfied the inclusion criteria and had received VFEND at least once.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 233
    <180 days
    24.56
    10.5%
    ≥180 days
    32.26
    13.8%
    6. Secondary Outcome
    Title Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate)
    Description IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 198
    Number (95% Confidence Interval) [Percentage of Participants]
    1.5
    0.6%
    7. Secondary Outcome
    Title Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Age
    Description IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 198
    <15 years
    1.5
    0.6%
    ≥15 years
    1.5
    0.6%
    8. Secondary Outcome
    Title Proportion of Participants Who Developed Invasive Fungal Infections (IFI Rate) by Reason for Use
    Description IFI rate, which was defined as the percentage of participants who developed invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician. In case of "with onset," it was classified as proven diagnosis, probable diagnosis, or possible case according to the diagnostic criteria of the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG). Participants judged as proven diagnosis or probable diagnosis were counted as those who developed invasive fungal infections for the calculation of IFI rate. Participants who developed invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 198
    Primary prophylaxis
    1.1
    0.5%
    Secondary prophylaxis
    7.1
    3%
    9. Secondary Outcome
    Title Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate)
    Description Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 198
    Number (95% Confidence Interval) [Percentage of Participants]
    97.5
    41.8%
    10. Secondary Outcome
    Title Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Age
    Description Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by age (<15 years, ≥15 years) to assess whether it contributes to the clinical effectiveness.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 198
    <15 years
    98.5
    42.3%
    ≥15 years
    96.9
    41.6%
    11. Secondary Outcome
    Title Proportion of Participants With Successful Prophylaxis of Invasive Fungal Infections (Success Rate) by Reason for Use
    Description Success rate, which was defined as the percentage of participants with successful prophylaxis of invasive fungal infections over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Presence or absence of invasive fungal infections was judged as "without onset," "with onset," or "indeterminate" by the physician, and participants judged as "without onset" were counted as those with successful prophylaxis of invasive fungal infections for the calculation of success rate. Participants with successful prophylaxis of invasive fungal infections were counted by reason for use to assess whether it contributes to the clinical effectiveness.
    Time Frame Maximum 3 years

    Outcome Measure Data

    Analysis Population Description
    The efficacy analysis set (EAS) comprised of participants in the safety analysis set for whom the presence/absence of invasive fungal infections has been evaluated, excluding those with no information on effectiveness or non-target disease. The EAS was 199 participants. Those assessed as "indeterminate (n=1)" was excluded from the calculation.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    Measure Participants 198
    Primary prophylaxis
    97.8
    42%
    Secondary prophylaxis
    92.9
    39.9%

    Adverse Events

    Time Frame 3 years at Maximum
    Adverse Event Reporting Description The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
    Arm/Group Title VFEND (Voriconazole)
    Arm/Group Description Participants who received VFEND as indicated in the approved local product document were observed for a period of 3 years at maximum. The dosage can be adjusted as per physician's discretion.
    All Cause Mortality
    VFEND (Voriconazole)
    Affected / at Risk (%) # Events
    Total 19/233 (8.2%)
    Serious Adverse Events
    VFEND (Voriconazole)
    Affected / at Risk (%) # Events
    Total 60/233 (25.8%)
    Blood and lymphatic system disorders
    Anaemia 1/233 (0.4%)
    Bone marrow failure 2/233 (0.9%)
    Febrile neutropenia 5/233 (2.1%)
    Immune thrombocytopenic purpura 1/233 (0.4%)
    Thrombotic microangiopathy 1/233 (0.4%)
    Cardiac disorders
    Arrhythmia 1/233 (0.4%)
    Cardiac failure 1/233 (0.4%)
    Cardiac failure acute 1/233 (0.4%)
    Cardiac failure chronic 1/233 (0.4%)
    Gastrointestinal disorders
    Diarrhoea 1/233 (0.4%)
    Gastrointestinal haemorrhage 1/233 (0.4%)
    Pancreatitis acute 1/233 (0.4%)
    General disorders
    Generalised oedema 1/233 (0.4%)
    Mucosal inflammation 1/233 (0.4%)
    Multiple organ dysfunction syndrome 1/233 (0.4%)
    Hepatobiliary disorders
    Cholecystitis 1/233 (0.4%)
    Hepatic function abnormal 1/233 (0.4%)
    Hepatitis acute 1/233 (0.4%)
    Venoocclusive liver disease 2/233 (0.9%)
    Immune system disorders
    Acute graft versus host disease 3/233 (1.3%)
    Acute graft versus host disease in intestine 1/233 (0.4%)
    Acute graft versus host disease in liver 1/233 (0.4%)
    Cytokine storm 1/233 (0.4%)
    Engraftment syndrome 1/233 (0.4%)
    Graft versus host disease 12/233 (5.2%)
    Graft versus host disease in lung 2/233 (0.9%)
    Primary amyloidosis 1/233 (0.4%)
    Infections and infestations
    Adenovirus infection 1/233 (0.4%)
    Pneumonia influenzal 1/233 (0.4%)
    Cytomegalovirus viraemia 1/233 (0.4%)
    Staphylococcal sepsis 1/233 (0.4%)
    Herpes virus infection 1/233 (0.4%)
    Meningoencephalitis herpetic 1/233 (0.4%)
    Bacteraemia 1/233 (0.4%)
    Psoas abscess 1/233 (0.4%)
    Tooth infection 1/233 (0.4%)
    Systemic candida 1/233 (0.4%)
    Systemic mycosis 1/233 (0.4%)
    Sepsis 1/233 (0.4%)
    Pneumonia 3/233 (1.3%)
    Lung abscess 1/233 (0.4%)
    Injury, poisoning and procedural complications
    Engraft failure 1/233 (0.4%)
    Investigations
    Aspartate aminotransferase increased 1/233 (0.4%)
    Blood bilirubin increased 3/233 (1.3%)
    Blood creatinine increased 2/233 (0.9%)
    Blood urea increased 1/233 (0.4%)
    Neutrophil count decreased 3/233 (1.3%)
    Platelet count decreased 2/233 (0.9%)
    Metabolism and nutrition disorders
    Tumour lysis syndrome 2/233 (0.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia recurrent 1/233 (0.4%)
    Acute myeloid leukaemia 1/233 (0.4%)
    Chronic myeloid leukaemia recurrent 1/233 (0.4%)
    Lymphoma 1/233 (0.4%)
    Myelodysplastic syndrome 2/233 (0.9%)
    Neoplasm progression 1/233 (0.4%)
    Nervous system disorders
    Cerebrovascular accident 1/233 (0.4%)
    Headache 1/233 (0.4%)
    Parkinsonism 1/233 (0.4%)
    Renal and urinary disorders
    Acute kidney injury 2/233 (0.9%)
    Nephrotic syndrome 1/233 (0.4%)
    Renal disorder 1/233 (0.4%)
    Renal failure 1/233 (0.4%)
    Renal impairment 4/233 (1.7%)
    Respiratory, thoracic and mediastinal disorders
    Hypercapnia 1/233 (0.4%)
    Idiopathic pneumonia syndrome 1/233 (0.4%)
    Pneumomediastinum 1/233 (0.4%)
    Pulmonary congestion 1/233 (0.4%)
    Respiratory failure 1/233 (0.4%)
    Skin and subcutaneous tissue disorders
    Subcutaneous emphysema 1/233 (0.4%)
    Vascular disorders
    Shock 1/233 (0.4%)
    Other (Not Including Serious) Adverse Events
    VFEND (Voriconazole)
    Affected / at Risk (%) # Events
    Total 229/233 (98.3%)
    Blood and lymphatic system disorders
    Febrile neutropenia 38/233 (16.3%)
    Hepatobiliary disorders
    Liver disorder 14/233 (6%)
    Immune system disorders
    Graft versus host disease 43/233 (18.5%)
    Infections and infestations
    Cytomegalovirus viraemia 11/233 (4.7%)
    Investigations
    Aspartate aminotransferase increased 24/233 (10.3%)
    Alanine aminotransferase increased 24/233 (10.3%)
    Gamma-glutamyltransferase increased 30/233 (12.9%)
    Platelet count decreased 14/233 (6%)
    Blood alkaline phosphatase increased 19/233 (8.2%)
    White blood cell count decreased 12/233 (5.2%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

    Results Point of Contact

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT02674685
    Other Study ID Numbers:
    • A1501106
    First Posted:
    Feb 4, 2016
    Last Update Posted:
    Jun 8, 2021
    Last Verified:
    Jun 1, 2021