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NCT00448357 · OUTCOME

Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant

Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen · Source last updated 2017-07-17

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
100 days post transplant

What was measured

GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include: * Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body * Blistering, causing the exposed skin surface to flake off in severe cases * Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected * Jaundice, or a yellowing of the skin, which can indicate liver damage * Excessive dryness of the mouth and throat, leading to ulcers * Dryness of the lungs, vagina and other surfaces

Analysis population: Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.

Groups in this outcome

Low Busulfan AUC Tertile

Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min

Intermediate Busulfan AUC Tertile

Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min

High Busulfan AUC Tertile

Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Low Busulfan AUC Tertile18
Intermediate Busulfan AUC Tertile18
High Busulfan AUC Tertile18

Reported measurements

Acute GVHD grade >=II
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Low Busulfan AUC Tertile7Not reportedNot reportedNot reportedNot reported
Intermediate Busulfan AUC Tertile10Not reportedNot reportedNot reportedNot reported
High Busulfan AUC Tertile11Not reportedNot reportedNot reportedNot reported
Acute GVHD grades III and IV
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Low Busulfan AUC Tertile2Not reportedNot reportedNot reportedNot reported
Intermediate Busulfan AUC Tertile4Not reportedNot reportedNot reportedNot reported
High Busulfan AUC Tertile3Not reportedNot reportedNot reportedNot reported
Chronic GVHD; intermediate/severe
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Low Busulfan AUC Tertile4Not reportedNot reportedNot reportedNot reported
Intermediate Busulfan AUC Tertile6Not reportedNot reportedNot reportedNot reported
High Busulfan AUC Tertile2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        11
    title
    Acute GVHD grade >=II
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
    title
    Acute GVHD grades III and IV
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
    title
    Chronic GVHD; intermediate/severe
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      18
    units
    Participants
description
GVHD can be mild, moderate or severe depending on the differences in tissue type between patient and donor. GVHD can be acute or chronic. Its symptoms can include: * Rashes, which include burning and redness, that erupt on the palms or soles and may spread to the trunk and eventually to the entire body * Blistering, causing the exposed skin surface to flake off in severe cases * Nausea, vomiting, abdominal cramps, diarrhea and loss of appetite, which can indicate that the gastrointestinal (digestive) tract is affected * Jaundice, or a yellowing of the skin, which can indicate liver damage * Excessive dryness of the mouth and throat, leading to ulcers * Dryness of the lungs, vagina and other surfaces
groups
  1. description
    Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 5078 (full range 3933-5615) microM/min
    id
    OG000
    title
    Low Busulfan AUC Tertile
  2. description
    Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 6372 (full range 5639-6965) microM/min
    id
    OG001
    title
    Intermediate Busulfan AUC Tertile
  3. description
    Participants with the lowest tertile of measured busulfan Area under the curve (AUC); with a mean value of 7605 (full range 7054-8863) microM/min
    id
    OG002
    title
    High Busulfan AUC Tertile
param Type
COUNT_OF_PARTICIPANTS
population Description
Because AUC levels varied between the groups and the goal was to identify an actual achieved AUC-based dose, additional outcome analyses were undertaken by dividing patients into thirds according to the actual AUCs delivered rather than the original planned AUCs.
reporting Status
POSTED
time Frame
100 days post transplant
title
Incidence of Graft vs Host Disease in Patients Between One Month and Two Years Post Transplant
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice