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NCT01499147 · OUTCOME

Time to ANC and Platelet Engraftment

Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies · Source last updated 2018-11-08

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

Measure
MEDIAN
Unit
days to ANC and platelet engraftment
Interval / dispersion
Full Range
Time frame
Up to 30 days post-transplant

What was measured

Days to ANC or platelet engraftment

Groups in this outcome

Fludarabine/Busulfan + ATG

All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI. ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.

Fludarabine/Melphalan + ATG

All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl). ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.

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

Analysis denominator · Participants

GroupSource count
Fludarabine/Busulfan + ATG18
Fludarabine/Melphalan + ATG12

Reported measurements

Source class 1
Values in days to ANC and platelet engraftment · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Fludarabine/Busulfan + ATG15Not reported024Not reported
Fludarabine/Melphalan + ATG12Not reported1022Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        24
        value
        15
      2. group Id
        OG001
        lower Limit
        10
        upper Limit
        22
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Days to ANC or platelet engraftment
dispersion Type
Full Range
groups
  1. description
    All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI. ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
    id
    OG000
    title
    Fludarabine/Busulfan + ATG
  2. description
    All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl). ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
    id
    OG001
    title
    Fludarabine/Melphalan + ATG
param Type
MEDIAN
reporting Status
POSTED
time Frame
Up to 30 days post-transplant
title
Time to ANC and Platelet Engraftment
type
SECONDARY
unit Of Measure
days to ANC and platelet engraftment

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

Preserved source evidence · Not medical advice