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NCT01305200 · OUTCOME

Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).

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
MEDIAN
Unit
mg/kg/day of opioid analgesics
Interval / dispersion
Full Range
Time frame
Day -1 (day prior to stem cell infusion) to Day 20 following transplantation.

What was measured

Morphine equivalent dose in mg/kg/day

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 mg/kg/day of opioid analgesics · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm I (Placebo)0.4Not reported033.2Not reported
Arm II (Supersaturated Calcium Phosphate Rinse)0.3Not reported013.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        33.2
        value
        0.4
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        13.4
        value
        0.3
denoms
  1. counts
    1. group Id
      OG000
      value
      106
    2. group Id
      OG001
      value
      104
    units
    Participants
description
Morphine equivalent dose in mg/kg/day
dispersion Type
Full Range
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
MEDIAN
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
Total Dose of Parenteral Opioid Analgesic Used (Morphine Equivalents).
type
SECONDARY
unit Of Measure
mg/kg/day of opioid analgesics

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

Preserved source evidence · Not medical advice