NCT01371656 · OUTCOME

Comparison of the Percentage of Patients That Died Due to Bacterial Infection 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

Analysis population: Evaluable patients combined from both AL and HSCT cohorts were reported. Ineligible and withdrew of Consent prior to Tx 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

Group	Source 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
Group	Value	Spread	Lower	Upper	Comment
Arm I (Levofloxacin)	0	Not reported	Not reported	Not reported	Not reported
Arm II (Standard of Care)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0

denoms

counts
group Id
OG000
value
306
group Id
OG001
value
307
units
Participants

groups

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)
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

Evaluable patients combined from both AL and HSCT cohorts were reported. Ineligible and withdrew of Consent prior to Tx were excluded.

reporting Status

POSTED

time Frame

Up to 60 days after enrollment or receiving levofloxacin

title

Comparison of the Percentage of Patients That Died Due to Bacterial Infection Between Arms

type

SECONDARY

unit Of Measure

Percentage of patients

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

Preserved source evidence · Not medical advice