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NCT00398411 · OUTCOME

Reason for Discontinuation of Treatment

Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells · Source last updated 2015-06-29

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)

What was measured

Absolute neutrophil count (ANC) recovered to \> 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever \>= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason

Analysis population: intention to treat (ITT)

Groups in this outcome

Moxifloxacin

moxifloxacin 400 mg tablets once daily

Placebo

identical appearing placebo

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

Analysis denominator · Participants

GroupSource count
Moxifloxacin34
Placebo32

Reported measurements

recovery of absolute neutrophil count
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin6Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
maximum of 20 days of treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin0Not reportedNot reportedNot reportedNot reported
Placebo0Not reportedNot reportedNot reportedNot reported
premature discontinuation: occurence of fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin18Not reportedNot reportedNot reportedNot reported
Placebo23Not reportedNot reportedNot reportedNot reported
premature discontinuation: antibiotic treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin1Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
premature discontinuation: death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin0Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
premature discontinuation: other adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin6Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
premature discontinuation: other reason
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Moxifloxacin3Not reportedNot reportedNot reportedNot reported
Placebo5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    title
    recovery of absolute neutrophil count
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    maximum of 20 days of treatment
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        23
    title
    premature discontinuation: occurence of fever
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    premature discontinuation: antibiotic treatment
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    premature discontinuation: death
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
    title
    premature discontinuation: other adverse event
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
    title
    premature discontinuation: other reason
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      32
    units
    Participants
description
Absolute neutrophil count (ANC) recovered to \> 500 /µl on two consecutive days Maximum of 20 days of treatment Occurrence of fever \>= 38°C Systemic antibiotic treatment despite patient being afebrile Death Other adverse event (AE) Other reason
groups
  1. description
    moxifloxacin 400 mg tablets once daily
    id
    OG000
    title
    Moxifloxacin
  2. description
    identical appearing placebo
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
intention to treat (ITT)
reporting Status
POSTED
time Frame
end of treatment (mean duration of treatment was 9.7 days; 10.2 days in moxifloxacin arm, 9.2 days in placebo arm)
title
Reason for Discontinuation of Treatment
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice