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NCT01305200 · OUTCOME

Incidence of Invasive Bacterial Infections

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
percentage of participants
Interval / dispersion
Not reported
Time frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

What was measured

Invasive Bacterial Infection = yes

Analysis population: Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).

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)106
Arm II (Supersaturated Calcium Phosphate Rinse)104

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm I (Placebo)6.6Not reportedNot reportedNot reportedNot reported
Arm II (Supersaturated Calcium Phosphate Rinse)7.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6.6
      2. group Id
        OG001
        value
        7.7
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    2. group Id
      OG001
      value
      104
    units
    Participants
description
Invasive Bacterial Infection = yes
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
Total of 210 patients evaluable for this assessment (106 Arm I \& 104 Arm II).
reporting Status
POSTED
time Frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.
title
Incidence of Invasive Bacterial Infections
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice