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NCT00513474 · OUTCOME

Uric Acid Levels

Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant · Source last updated 2017-05-25

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

Measure
MEAN
Unit
mg/dL
Interval / dispersion
Standard Deviation
Time frame
Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6

What was measured

Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant.

Analysis population: Intent-to-treat population with data available for analyses.

Groups in this outcome

Rasburicase Group

Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.

Control Group

Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.

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

Analysis denominator · Participants

GroupSource count
Rasburicase Group21
Control Group21

Reported measurements

Day -7
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.10.209Not reportedNot reportedNot reported
Control Group4.1571.886Not reportedNot reportedNot reported
Day -6
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.0750.199Not reportedNot reportedNot reported
Control Group3.4191.752Not reportedNot reportedNot reported
Day -5
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.0860.24Not reportedNot reportedNot reported
Control Group2.9671.437Not reportedNot reportedNot reported
Day -4
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.10.324Not reportedNot reportedNot reported
Control Group2.5791.249Not reportedNot reportedNot reported
Day -3
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.0670.2Not reportedNot reportedNot reported
Control Group2.3581.21Not reportedNot reportedNot reported
Day -2
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.0810.15Not reportedNot reportedNot reported
Control Group1.8671.097Not reportedNot reportedNot reported
Day -1
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.4380.611Not reportedNot reportedNot reported
Control Group1.710.931Not reportedNot reportedNot reported
Day 0
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group0.9380.887Not reportedNot reportedNot reported
Control Group2.1631.012Not reportedNot reportedNot reported
Day 1
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group1.6241.205Not reportedNot reportedNot reported
Control Group2.6711.056Not reportedNot reportedNot reported
Day 2
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group2.0761.37Not reportedNot reportedNot reported
Control Group2.7780.985Not reportedNot reportedNot reported
Day 3
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group2.2711.303Not reportedNot reportedNot reported
Control Group2.8051.028Not reportedNot reportedNot reported
Day 4
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group2.5481.454Not reportedNot reportedNot reported
Control Group2.7581.161Not reportedNot reportedNot reported
Day 5
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group2.5951.729Not reportedNot reportedNot reported
Control Group2.5791.318Not reportedNot reportedNot reported
Day 6
Values in mg/dL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rasburicase Group2.7051.665Not reportedNot reportedNot reported
Control Group2.6531.33Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.209
        value
        0.1
      2. group Id
        OG001
        spread
        1.886
        value
        4.157
    title
    Day -7
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.199
        value
        0.075
      2. group Id
        OG001
        spread
        1.752
        value
        3.419
    title
    Day -6
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.24
        value
        0.086
      2. group Id
        OG001
        spread
        1.437
        value
        2.967
    title
    Day -5
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.324
        value
        0.1
      2. group Id
        OG001
        spread
        1.249
        value
        2.579
    title
    Day -4
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.2
        value
        0.067
      2. group Id
        OG001
        spread
        1.21
        value
        2.358
    title
    Day -3
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.15
        value
        0.081
      2. group Id
        OG001
        spread
        1.097
        value
        1.867
    title
    Day -2
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.611
        value
        0.438
      2. group Id
        OG001
        spread
        0.931
        value
        1.71
    title
    Day -1
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.887
        value
        0.938
      2. group Id
        OG001
        spread
        1.012
        value
        2.163
    title
    Day 0
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.205
        value
        1.624
      2. group Id
        OG001
        spread
        1.056
        value
        2.671
    title
    Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.37
        value
        2.076
      2. group Id
        OG001
        spread
        0.985
        value
        2.778
    title
    Day 2
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.303
        value
        2.271
      2. group Id
        OG001
        spread
        1.028
        value
        2.805
    title
    Day 3
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.454
        value
        2.548
      2. group Id
        OG001
        spread
        1.161
        value
        2.758
    title
    Day 4
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      21
    units
    Participants
description
Blood was collected and analyzed at a laboratory for serum uric acid levels reported in milligrams(mg)/deciliter(dL). Data is presented for those participants who experienced Grade II to IV aGVHD and those participants who did not experience Grade II to IV aGVHD at pre-transplant and post-transplant.
dispersion Type
Standard Deviation
groups
  1. description
    Myeloablative (bone marrow depletion) conditioning protocol as per standard of care at the investigator's discretion followed by granulocyte colony-stimulating factor (GCSF)-mobilized human leukocyte antigen (HLA)-matched, related or unrelated donor allogeneic peripheral blood stem cells (unmanipulated), standard graft-versus-host disease (GVHD) prophylaxis as per standard of care at the investigator's discretion and rasburicase 0.20 mg/kg/day administered by intravenous infusion for 5 consecutive days. If after 5 days of rasburicase the participant's uric acid plasma level remains above 5 mg/dL, rasburicase may be continued for up to 7 days in total.
    id
    OG000
    title
    Rasburicase Group
  2. description
    Historical chart review of patients from the Blood and Marrow Transplant database who received myeloablative allogeneic stem cell/bone marrow transplantation followed by standard GVHD prophylaxis in the past 10 years. Participants received allopurinol per institutional guidelines.
    id
    OG001
    title
    Control Group
param Type
MEAN
population Description
Intent-to-treat population with data available for analyses.
reporting Status
POSTED
time Frame
Pre-transplant Day -7 to Day -1 and Post-transplant Day 0 to Day 6
title
Uric Acid Levels
type
SECONDARY
unit Of Measure
mg/dL

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Preserved source evidence · Not medical advice