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NCT02098109 · OUTCOME

Comparison of the Readmission Rate Between the Two Arms

Non-inferiority Study of XM02 Filgrastim (Granix) and Filgrastim (Neupogen) in Combination With Plerixafor for Autologous Stem Cell Mobilization in Patients With Multiple Myeloma or Non-Hodgkin Lymphoma · Source last updated 2017-07-18

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 Day 100

What was measured

Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse

Analysis population: (2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.

Groups in this outcome

XM02 Filgrastim (Granix) and Plerixafor

XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)

Filgrastim (Neupogen) and Plerixafor

Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)

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

Analysis denominator · Participants

GroupSource count
XM02 Filgrastim (Granix) and Plerixafor44
Filgrastim (Neupogen) and Plerixafor50

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor11Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        9
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      50
    units
    Participants
description
Readmission rate is defined as the frequency at which patients are readmitted (after initial post-transplant discharge) following post-infusion of mobilized PBSC product for reasons other than progressive disease/relapse
groups
  1. description
    XM02 Filgrastim (Granix) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    OG000
    title
    XM02 Filgrastim (Granix) and Plerixafor
  2. description
    Filgrastim (Neupogen) 10 mg/kg Days 1 through 4 (Days 5 through 8 may be required if target collection goal has not be met) Plerixafor 0.24 mg/kg Day 4 (Days 5 through 7 may be required if target collection goal has not be met) Apheresis on Day 5 (may need to be done on Days 6-8 if target collection goal has not been met)
    id
    OG001
    title
    Filgrastim (Neupogen) and Plerixafor
param Type
COUNT_OF_PARTICIPANTS
population Description
(2) participants in the XM02 Filgrastim (Granix) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure. (1) participant in the Filgrastim (Neupogen) \& Plerixafor arm did not receive ASCT and were not evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to Day 100
title
Comparison of the Readmission Rate Between the Two Arms
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice