Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01305200 · OUTCOME

Incidence of Severe Oral Mucositis

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
NUMBER
Unit
percent of patients
Interval / dispersion
Not reported
Time frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

What was measured

Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.

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 percent of patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Placebo)68Not reportedNot reportedNot reportedNot reported
Arm II (Supersaturated Calcium Phosphate Rinse)63Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        68
      2. group Id
        OG001
        value
        63
denoms
  1. counts
    1. group Id
      OG000
      value
      91
    2. group Id
      OG001
      value
      91
    units
    Participants
description
Percentage of patients with Severe Oral Mucositis (WHO Grade 3 or 4) per arm.
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
NUMBER
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
Incidence of Severe Oral Mucositis
type
SECONDARY
unit Of Measure
percent of patients

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

Preserved source evidence · Not medical advice