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NCT01653418 · OUTCOME

Time to Platelet Engraftment After V-BEAM.

Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation · Source last updated 2014-10-15

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Day +100

What was measured

Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at \> 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.

Analysis population: Two participants without evaluable responses due to early mortality were not included in this analysis.

Groups in this outcome

V-BEAM + Stem Cell Infusion

Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0

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

Analysis denominator · Participants

GroupSource count
V-BEAM + Stem Cell Infusion8

Reported measurements

More than 20 x 10^9/L
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion22.5Not reported1736Not reported
More than 50 x 10^9/L
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion23Not reported1746Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17
        upper Limit
        36
        value
        22.5
    title
    More than 20 x 10^9/L
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17
        upper Limit
        46
        value
        23
    title
    More than 50 x 10^9/L
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at \> 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.
dispersion Type
Full Range
groups
  1. description
    Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
    id
    OG000
    title
    V-BEAM + Stem Cell Infusion
param Type
MEDIAN
population Description
Two participants without evaluable responses due to early mortality were not included in this analysis.
reporting Status
POSTED
time Frame
Day +100
title
Time to Platelet Engraftment After V-BEAM.
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice