NCT01305200 · OUTCOME

Oral Mucositis Daily Questionnaire (OMDQ)

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: units on a scale * day
Interval / dispersion: Standard Deviation
Time frame: Day -1 (day prior to stem cell infusion) to Day 20 following transplantation

What was measured

Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales

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

Group	Source count
Arm I (Placebo)	91
Arm II (Supersaturated Calcium Phosphate Rinse)	91

Reported measurements

Sleeping

Values in units on a scale * day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo)	9.3	10.9	Not reported	Not reported	Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)	7.3	9	Not reported	Not reported	Not reported

Mouth and Throat Pain

Values in units on a scale * day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo)	22.3	14.8	Not reported	Not reported	Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)	21.4	14.7	Not reported	Not reported	Not reported

Swallowing

Values in units on a scale * day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo)	21.4	15.7	Not reported	Not reported	Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)	19.9	15.9	Not reported	Not reported	Not reported

Drinking

Values in units on a scale * day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo)	21.7	16.3	Not reported	Not reported	Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)	20.6	17.3	Not reported	Not reported	Not reported

Eating

Values in units on a scale * day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo)	27.9	19.4	Not reported	Not reported	Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)	26.6	20.7	Not reported	Not reported	Not reported

Talking

Values in units on a scale * day · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Arm I (Placebo)	12.2	11.5	Not reported	Not reported	Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)	12	13.2	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
10.9
value
9.3
group Id
OG001
spread
9
value
7.3
title
Sleeping
categories
measurements
group Id
OG000
spread
14.8
value
22.3
group Id
OG001
spread
14.7
value
21.4
title
Mouth and Throat Pain
categories
measurements
group Id
OG000
spread
15.7
value
21.4
group Id
OG001
spread
15.9
value
19.9
title
Swallowing
categories
measurements
group Id
OG000
spread
16.3
value
21.7
group Id
OG001
spread
17.3
value
20.6
title
Drinking
categories
measurements
group Id
OG000
spread
19.4
value
27.9
group Id
OG001
spread
20.7
value
26.6
title
Eating
categories
measurements
group Id
OG000
spread
11.5
value
12.2
group Id
OG001
spread
13.2
value
12
title
Talking

denoms

counts
group Id
OG000
value
91
group Id
OG001
value
91
units
Participants

description

Area under the curve (AUC) of the Oral Mucositis Daily Questionnaire (OMDQ) subscales

dispersion Type

Standard Deviation

groups

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)
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

Oral Mucositis Daily Questionnaire (OMDQ)

type

SECONDARY

unit Of Measure

units on a scale * day

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

Preserved source evidence · Not medical advice