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NCT01371656 · OUTCOME

Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms

Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation · Source last updated 2020-12-07

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

Measure
NUMBER
Unit
Percentage of patients
Interval / dispersion
Not reported
Time frame
Up to 60 days after enrollment or receiving levofloxacin

What was measured

A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.

Analysis population: All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.

Groups in this outcome

Arm I (Levofloxacin)

Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover. levofloxacin: Given PO or IV

Arm II (Standard of Care)

Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.

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 (Levofloxacin)306
Arm II (Standard of Care)307

Reported measurements

Evaluable AL patients

Analysis denominator · Participants

GroupSource count
Arm I (Levofloxacin)96
Arm II (Standard of Care)99
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Levofloxacin)21.9Not reportedNot reportedNot reportedNot reported
Arm II (Standard of Care)43.4Not reportedNot reportedNot reportedNot reported
Evaluable HSCT patients

Analysis denominator · Participants

GroupSource count
Arm I (Levofloxacin)210
Arm II (Standard of Care)208
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Levofloxacin)11Not reportedNot reportedNot reportedNot reported
Arm II (Standard of Care)17.3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21.9
      2. group Id
        OG001
        value
        43.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        99
      units
      Participants
    title
    Evaluable AL patients
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        17.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        210
      2. group Id
        OG001
        value
        208
      units
      Participants
    title
    Evaluable HSCT patients
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      307
    units
    Participants
description
A bacteremia incidence is defined as an occurrence of at least 1 episode of true (centrally reviewed) bacteremia among Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) patients.
groups
  1. description
    Patients receive levofloxacin PO or IV over 60-90 minutes once or twice daily beginning on day 3 during 2 consecutive courses of chemotherapy or beginning on day -2 during HSCT and continuing until blood counts recover. levofloxacin: Given PO or IV
    id
    OG000
    title
    Arm I (Levofloxacin)
  2. description
    Patients receive established standard of care and receive chemotherapy or HSCT as patients in Arm I.
    id
    OG001
    title
    Arm II (Standard of Care)
param Type
NUMBER
population Description
All evaluable, and centrally reviewed AL and HSCT patients are reported. Ineligible patients and patients who withdrew of consent prior to treatment were excluded.
reporting Status
POSTED
time Frame
Up to 60 days after enrollment or receiving levofloxacin
title
Comparison of the Percentage of Patients Having Bacteremia Incidence Between Levofloxacin vs. No Prophylaxis Arms
type
PRIMARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice