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NCT02037256 · OUTCOME

Time to Neutrophil Engraftment

Bortezomib and Filgrastim to Promote Stem Cell Mobilization in Patients With Non-Hodgkin Lymphoma or Multiple Myeloma · Source last updated 2021-05-10

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

Measure
MEDIAN
Unit
days to ANC 500
Interval / dispersion
95% Confidence Interval
Time frame
Up to 6 months

What was measured

Estimated Median Time to Neutrophil Engraftment, ANC 500

Analysis population: Evaluable patients

Groups in this outcome

Arm A Standard of Care Mobilization

G-CSF 16 mcg/kg/day for 9 days; Bortezomib 1.3 mg/m2 IV on day 6. Blood draws and apheresis on days 5-9.

Arm B Alternative Mobilization

G-CSF16 mcg/kg/day for 8 days; Bortezomib on days 4 and 7. Blood collection on days 4 \& 8, apheresis on days 5-8.

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

Analysis denominator · Participants

GroupSource count
Arm A Standard of Care Mobilization3
Arm B Alternative Mobilization17

Reported measurements

Source class 1
Values in days to ANC 500 · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A Standard of Care Mobilization12Not reported12NATwo few observations to calculate upper limit
Arm B Alternative Mobilization13Not reported1214Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.07
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.50
    group Description
    Median time to engraftment
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    param Type
    percentage
    param Value
    0.24
Complete source fields
analyses
  1. ci Lower Limit
    0.07
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.50
    group Description
    Median time to engraftment
    group Ids
    1. OG001
    non Inferiority Type
    OTHER
    param Type
    percentage
    param Value
    0.24
classes
  1. categories
    1. measurements
      1. comment
        Two few observations to calculate upper limit
        group Id
        OG000
        lower Limit
        12
        upper Limit
        NA
        value
        12
      2. group Id
        OG001
        lower Limit
        12
        upper Limit
        14
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      17
    units
    Participants
description
Estimated Median Time to Neutrophil Engraftment, ANC 500
dispersion Type
95% Confidence Interval
groups
  1. description
    G-CSF 16 mcg/kg/day for 9 days; Bortezomib 1.3 mg/m2 IV on day 6. Blood draws and apheresis on days 5-9.
    id
    OG000
    title
    Arm A Standard of Care Mobilization
  2. description
    G-CSF16 mcg/kg/day for 8 days; Bortezomib on days 4 and 7. Blood collection on days 4 \& 8, apheresis on days 5-8.
    id
    OG001
    title
    Arm B Alternative Mobilization
param Type
MEDIAN
population Description
Evaluable patients
reporting Status
POSTED
time Frame
Up to 6 months
title
Time to Neutrophil Engraftment
type
SECONDARY
unit Of Measure
days to ANC 500

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

Preserved source evidence · Not medical advice