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NCT02112045 · OUTCOME

Number of Participants With Neutrophil Engraftment

A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation · Source last updated 2019-11-26

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 30

What was measured

Neutrophil engraftment is defined as ANC ≥ 0.5 × 10\^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC ≥ 0.5 × 109/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.

Groups in this outcome

Experimental: Granix and High Dose Melphalan (HDM)

Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0

Control: High Dose Melphalan (HDM)

HDM intravenously (IV) on Day -2.

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

Analysis denominator · Participants

GroupSource count
Experimental: Granix and High Dose Melphalan (HDM)44
Control: High Dose Melphalan (HDM)45

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: Granix and High Dose Melphalan (HDM)44Not reportedNot reportedNot reportedNot reported
Control: High Dose Melphalan (HDM)45Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        45
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      45
    units
    Participants
description
Neutrophil engraftment is defined as ANC ≥ 0.5 × 10\^9/L × 3 consecutive daily assessments. The first of 3 consecutive days for which ANC ≥ 0.5 × 109/L will be recorded as the date of neutrophil engraftment. Time to neutrophil engraftment will be calculated as the time from the date of the ASCT to the date of neutrophil engraftment.
groups
  1. description
    Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
    id
    OG000
    title
    Experimental: Granix and High Dose Melphalan (HDM)
  2. description
    HDM intravenously (IV) on Day -2.
    id
    OG001
    title
    Control: High Dose Melphalan (HDM)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to Day 30
title
Number of Participants With Neutrophil Engraftment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice