NCT00103610 · OUTCOME

Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma Patients · Source last updated 2014-03-13

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

Measure: NUMBER
Unit: proportion of participants
Interval / dispersion: Not reported
Time frame: up to Day 8

What was measured

Proportion of participants achieving a target of \>=2\*10\^6 CD34+ Cells/kg in 4 or fewer days of apheresis. Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period. Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.

Analysis population: Intent-to-treat Population

Groups in this outcome

G-CSF Plus Plerixafor

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

G-CSF Plus Placebo

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.

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

Analysis denominator · Participants

Group	Source count
G-CSF Plus Plerixafor	150
G-CSF Plus Placebo	148

Reported measurements

Proportion achieving target in ≤4 days

Values in proportion of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
G-CSF Plus Plerixafor	0.867	Not reported	Not reported	Not reported	Not reported
G-CSF Plus Placebo	0.473	Not reported	Not reported	Not reported	Not reported

Proportion not achieving target in ≤4 days

Values in proportion of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
G-CSF Plus Plerixafor	0.133	Not reported	Not reported	Not reported	Not reported
G-CSF Plus Placebo	0.527	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0.867
group Id
OG001
value
0.473
title
Proportion achieving target in ≤4 days
categories
measurements
group Id
OG000
value
0.133
group Id
OG001
value
0.527
title
Proportion not achieving target in ≤4 days

denoms

counts
group Id
OG000
value
150
group Id
OG001
value
148
units
Participants

description

groups

description
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
id
OG000
title
G-CSF Plus Plerixafor
description
Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
id
OG001
title
G-CSF Plus Placebo

param Type

NUMBER

population Description

Intent-to-treat Population

reporting Status

POSTED

time Frame

up to Day 8

title

Proportion of Participants Able to Achieve Target (>=2*10^6 CD34+ Cells/kg) in 4 or Fewer Days of Apheresis

type

SECONDARY

unit Of Measure

proportion of participants

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Preserved source evidence · Not medical advice