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NCT01371656 · OUTCOME

Comparison of the Percentage of Patients Having Incidence of CDAD Between 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

Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher.

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

Source class 1
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Levofloxacin)2.3Not reportedNot reportedNot reportedNot reported
Arm II (Standard of Care)5.2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.3
      2. group Id
        OG001
        value
        5.2
denoms
  1. counts
    1. group Id
      OG000
      value
      306
    2. group Id
      OG001
      value
      307
    units
    Participants
description
Clostridium Difficile Associated Disease (CDAD) is defined as a positive C. difficile toxin assay result and diarrhea, CTCAE version 4, grade 2 and higher.
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 Incidence of CDAD Between Arms
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice