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NCT01307579 · OUTCOME

Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)

Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia · Source last updated 2021-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5 months since enrollment

What was measured

Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.

Analysis population: Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)

Groups in this outcome

Arm I (Caspofungin Acetate)

Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \> 100-500/uL following the nadir or the next chemotherapy course begins. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies

Arm II (Fluconazole)

Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm I (Caspofungin Acetate)253
Arm II (Fluconazole)255

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (Caspofungin Acetate)0.5Not reported0.13.5Not reported
Arm II (Fluconazole)3.1Not reported1.46.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        3.5
        value
        0.5
      2. group Id
        OG001
        lower Limit
        1.4
        upper Limit
        6.9
        value
        3.1
denoms
  1. counts
    1. group Id
      OG000
      value
      253
    2. group Id
      OG001
      value
      255
    units
    Participants
description
Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \> 100-500/uL following the nadir or the next chemotherapy course begins. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    OG000
    title
    Arm I (Caspofungin Acetate)
  2. description
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    id
    OG001
    title
    Arm II (Fluconazole)
param Type
NUMBER
population Description
Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
reporting Status
POSTED
time Frame
Up to 5 months since enrollment
title
Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice