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NCT00103662 · OUTCOME

Median Number of Days to ≥6*10^6 CD34+ Cells/kg

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients · Source last updated 2014-03-13

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
Inter-Quartile Range
Time frame
up to Day 8

What was measured

The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6\*10\^6 CD34+ cells/kg) for transplantation.

Analysis population: Intent-to-treat population

Groups in this outcome

G-CSF Plus Plerixafor

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.

G-CSF Plus Placebo

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.

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

Analysis denominator · Participants

GroupSource count
G-CSF Plus Plerixafor144
G-CSF Plus Placebo150

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor1.0Not reported1.02.0Not reported
G-CSF Plus Placebo4.0Not reported2.0NANot enough participants reached the threshold to support estimating the upper range.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        2.0
        value
        1.0
      2. comment
        Not enough participants reached the threshold to support estimating the upper range.
        group Id
        OG001
        lower Limit
        2.0
        upper Limit
        NA
        value
        4.0
denoms
  1. counts
    1. group Id
      OG000
      value
      144
    2. group Id
      OG001
      value
      150
    units
    Participants
description
The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6\*10\^6 CD34+ cells/kg) for transplantation.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.
    id
    OG000
    title
    G-CSF Plus Plerixafor
  2. description
    Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.
    id
    OG001
    title
    G-CSF Plus Placebo
param Type
MEDIAN
population Description
Intent-to-treat population
reporting Status
POSTED
time Frame
up to Day 8
title
Median Number of Days to ≥6*10^6 CD34+ Cells/kg
type
SECONDARY
unit Of Measure
Days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice