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NCT01894477 · OUTCOME

Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia · Source last updated 2021-06-03

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
Up to 84 days

Groups in this outcome

Arm A (Treosulfan, Fludarabine Phosphate)

Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.

Arm B (Treosulfan, Fludarabine Phosphate, TBI)

Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.

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 A (Treosulfan, Fludarabine Phosphate)35
Arm B (Treosulfan, Fludarabine Phosphate, TBI)65

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Treosulfan, Fludarabine Phosphate)29Not reportedNot reportedNot reportedNot reported
Arm B (Treosulfan, Fludarabine Phosphate, TBI)50Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        50
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      65
    units
    Participants
groups
  1. description
    Treosulfan IV over 2 hours on days -6 to -4 and fludarabine phosphate IV over 30 minutes on days -6 to -2.
    id
    OG000
    title
    Arm A (Treosulfan, Fludarabine Phosphate)
  2. description
    Treosulfan and fludarabine phosphate as in Arm A and undergo low-dose TBI on day 0.
    id
    OG001
    title
    Arm B (Treosulfan, Fludarabine Phosphate, TBI)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 84 days
title
Number of Participants With Acute GVHD, Graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice