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NCT01371656 · OUTCOME

Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) 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
Enrollment, 2 months and 12 months post infection observation period

What was measured

Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy.

Analysis population: Evaluable patients who submitted musculoskeletal Case Record Form (CRF) combined from both Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) cohorts at enrollment. Ineligible and 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)303
Arm II (Standard of Care)300

Reported measurements

Evaluable AL and HSCT Patients at Baseline

Analysis denominator · Participants

GroupSource count
Arm I (Levofloxacin)303
Arm II (Standard of Care)300
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Levofloxacin)5.9Not reportedNot reportedNot reportedNot reported
Arm II (Standard of Care)10Not reportedNot reportedNot reportedNot reported
Evaluable AL and HSCT Patients at 2 Months

Analysis denominator · Participants

GroupSource count
Arm I (Levofloxacin)201
Arm II (Standard of Care)240
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Levofloxacin)11.4Not reportedNot reportedNot reportedNot reported
Arm II (Standard of Care)16.3Not reportedNot reportedNot reportedNot reported
Evaluable AL and HSCT Patients at 12 Months

Analysis denominator · Participants

GroupSource count
Arm I (Levofloxacin)129
Arm II (Standard of Care)146
Values in Percentage of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Levofloxacin)10.1Not reportedNot reportedNot reportedNot reported
Arm II (Standard of Care)14.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5.9
      2. group Id
        OG001
        value
        10
    denoms
    1. counts
      1. group Id
        OG000
        value
        303
      2. group Id
        OG001
        value
        300
      units
      Participants
    title
    Evaluable AL and HSCT Patients at Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11.4
      2. group Id
        OG001
        value
        16.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        201
      2. group Id
        OG001
        value
        240
      units
      Participants
    title
    Evaluable AL and HSCT Patients at 2 Months
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10.1
      2. group Id
        OG001
        value
        14.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        129
      2. group Id
        OG001
        value
        146
      units
      Participants
    title
    Evaluable AL and HSCT Patients at 12 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      303
    2. group Id
      OG001
      value
      300
    units
    Participants
description
Musculoskeletal conditions included at least one occurrence of arthralgia, arthritis, gait abnormality or tendinopathy.
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
Evaluable patients who submitted musculoskeletal Case Record Form (CRF) combined from both Acute Leukemia (AL) and Hematopoietic stem cell transplantation (HSCT) cohorts at enrollment. Ineligible and withdrew of Consent prior to treatment were excluded.
reporting Status
POSTED
time Frame
Enrollment, 2 months and 12 months post infection observation period
title
Comparison of the Percentage of Patients Having Incidence of Musculoskeletal Adverse Events Including Tendinopathy (Tendonitis and Tendon Rupture) Between Arms
type
SECONDARY
unit Of Measure
Percentage of patients

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

Preserved source evidence · Not medical advice