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NCT02098109 · OUTCOME

Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants 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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 20 days after last apheresis (Day 25-Day 28)

What was measured

-Adverse events will be assessed using CTCAE version 4.0

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 Plerixafor46
Filgrastim (Neupogen) and Plerixafor51

Reported measurements

Bone pain
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor19Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor22Not reportedNot reportedNot reportedNot reported
Thrombocytopenia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor18Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor20Not reportedNot reportedNot reportedNot reported
Anemia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor13Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor18Not reportedNot reportedNot reportedNot reported
Alkaline phosphatase increased
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor10Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor12Not reportedNot reportedNot reportedNot reported
Nausea and/or vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor10Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor10Not reportedNot reportedNot reportedNot reported
Leukocytosis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
XM02 Filgrastim (Granix) and Plerixafor8Not reportedNot reportedNot reportedNot reported
Filgrastim (Neupogen) and Plerixafor10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        22
    title
    Bone pain
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        20
    title
    Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        18
    title
    Anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        12
    title
    Alkaline phosphatase increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
    title
    Nausea and/or vomiting
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        10
    title
    Leukocytosis
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      51
    units
    Participants
description
-Adverse events will be assessed using CTCAE version 4.0
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
NUMBER
reporting Status
POSTED
time Frame
Up to 20 days after last apheresis (Day 25-Day 28)
title
Comparison of the Most Commonly Reported Adverse Events (Safety) Experienced by Participants Between the Two Arms
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice