NCT01458288 · OUTCOME

the Average Number of Leukapheresis Sessions

A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease · Source last updated 2021-04-19

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

Measure: MEAN
Unit: number of leukapheresis sessions
Interval / dispersion: Standard Deviation
Time frame: 1 week

What was measured

To determine the average number of leukapheresis sessions required to collect 2.5 x10\^6 CD34+ cells/kg.

Groups in this outcome

TG-0054 (3.14 mg/kg)

Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.

TG-0054 (3.14 mg/kg)+G-CSF

Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.

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
TG-0054 (3.14 mg/kg)	7
TG-0054 (3.14 mg/kg)+G-CSF	5

Reported measurements

Source class 1

Values in number of leukapheresis sessions · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
TG-0054 (3.14 mg/kg)	2.0	0.82	Not reported	Not reported	Not reported
TG-0054 (3.14 mg/kg)+G-CSF	1.4	0.55	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.82
value
2.0
group Id
OG001
spread
0.55
value
1.4

denoms

counts
group Id
OG000
value
7
group Id
OG001
value
5
units
Participants

description

To determine the average number of leukapheresis sessions required to collect 2.5 x10\^6 CD34+ cells/kg.

dispersion Type

Standard Deviation

groups

description
Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
id
OG000
title
TG-0054 (3.14 mg/kg)
description
Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
id
OG001
title
TG-0054 (3.14 mg/kg)+G-CSF

param Type

MEAN

reporting Status

POSTED

time Frame

1 week

title

the Average Number of Leukapheresis Sessions

type

SECONDARY

unit Of Measure

number of leukapheresis sessions

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

Preserved source evidence · Not medical advice