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NCT01305200 · OUTCOME

Duration of Severe Oral Mucositis (WHO Grade 3 or 4)

Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant · Source last updated 2019-09-17

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

Measure
MEAN
Unit
Number of days
Interval / dispersion
Standard Deviation
Time frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

What was measured

Mean days of severe (WHO Grade 3 or 4) Mucositis.

Analysis population: Evaluable patients defined as patients with \>= 11 daily WHO assessments.

Groups in this outcome

Arm I (Placebo)

Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies

Arm II (Supersaturated Calcium Phosphate Rinse)

Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies

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 (Placebo)91
Arm II (Supersaturated Calcium Phosphate Rinse)91

Reported measurements

Source class 1
Values in Number of days · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm I (Placebo)4.54.8Not reportedNot reportedNot reported
Arm II (Supersaturated Calcium Phosphate Rinse)4.55Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.8
        value
        4.5
      2. group Id
        OG001
        spread
        5
        value
        4.5
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      91
    units
    Participants
description
Mean days of severe (WHO Grade 3 or 4) Mucositis.
dispersion Type
Standard Deviation
groups
  1. description
    Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
    id
    OG000
    title
    Arm I (Placebo)
  2. description
    Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
    id
    OG001
    title
    Arm II (Supersaturated Calcium Phosphate Rinse)
param Type
MEAN
population Description
Evaluable patients defined as patients with \>= 11 daily WHO assessments.
reporting Status
POSTED
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
title
Duration of Severe Oral Mucositis (WHO Grade 3 or 4)
type
PRIMARY
unit Of Measure
Number of days

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

Preserved source evidence · Not medical advice