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NCT02112045 · OUTCOME

Number of Participants With Platelet 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 100

What was measured

Platelet engraftment is defined as an untransfused platelet measurement \>20,000/mm3 × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is \>20,000/mm3 will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.

Analysis population: 1 participant in control arm did not have a decrease in platelets and is not evaluable for this outcome measure.

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)44

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)44Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        44
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      44
    units
    Participants
description
Platelet engraftment is defined as an untransfused platelet measurement \>20,000/mm3 × 3 consecutive daily assessments. The first of 3 consecutive days for which the untransfused platelet measurement is \>20,000/mm3 will be recorded as the date of platelet engraftment. Time to platelet engraftment will be calculated as the time from receiving the date of ASCT to the date of platelet engraftment. Untransfused is defined as no transfusions within 7 days.
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
population Description
1 participant in control arm did not have a decrease in platelets and is not evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to Day 100
title
Number of Participants With Platelet Engraftment
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice