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NCT01292486 · OUTCOME

Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.

Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure · Source last updated 2013-05-01

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
up to 28 days following transplant

What was measured

Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease. As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D \> \|2\|, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery.

Analysis population: Twenty-six patients were evaluable per protocol.

Groups in this outcome

Patients With Multiple Myeloma

Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.

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

Analysis denominator · Participants

GroupSource count
Patients With Multiple Myeloma26

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Patients With Multiple Myeloma0Not reported-12Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0
    group Description
    The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.
    group Ids
    1. OG000
    non Inferiority Comment
    The non-inferiority margin was 2 days.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <0.025
    param Type
    Median Difference (Final Values)
    param Value
    0
    statistical Method
    Hodges-Lehman estimation
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Lower Limit
    0.0
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.0
    group Description
    The null hypothesis was that the median day to neutrophil recovery in this study was more than two days longer than historical controls.
    group Ids
    1. OG000
    non Inferiority Comment
    The non-inferiority margin was 2 days.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <0.025
    param Type
    Median Difference (Final Values)
    param Value
    0
    statistical Method
    Hodges-Lehman estimation
    tested Non Inferiority
    true
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -1
        upper Limit
        2
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease. As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D \> \|2\|, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery.
dispersion Type
Full Range
groups
  1. description
    Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
    id
    OG000
    title
    Patients With Multiple Myeloma
param Type
MEDIAN
population Description
Twenty-six patients were evaluable per protocol.
reporting Status
POSTED
time Frame
up to 28 days following transplant
title
Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
type
PRIMARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice