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NCT01458288 · OUTCOME

Circulating CD34+ Cell Count in Peripheral Blood

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
MEDIAN
Unit
cells/kg
Interval / dispersion
Full Range
Time frame
pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.

What was measured

Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.

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

GroupSource count
TG-0054 (3.14 mg/kg)7
TG-0054 (3.14 mg/kg)+G-CSF5

Reported measurements

Source class 1
Values in cells/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
TG-0054 (3.14 mg/kg)6000000Not reported400000010000000Not reported
TG-0054 (3.14 mg/kg)+G-CSF5000000Not reported400000021000000Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4000000
        upper Limit
        10000000
        value
        6000000
      2. group Id
        OG001
        lower Limit
        4000000
        upper Limit
        21000000
        value
        5000000
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Calculate the median total CD34+ cell counts across all leukapheresis sessions following TG 0054 administration alone and in combination with G-CSF mobilization in order to evaluate the pharmacodynamics (PD) of TG-0054 by determining circulating CD34+ cell counts in peripheral blood.
dispersion Type
Full Range
groups
  1. 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)
  2. 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
MEDIAN
reporting Status
POSTED
time Frame
pre-dose(-2 to 0 h),2, 4 and 6 hr after dosing.
title
Circulating CD34+ Cell Count in Peripheral Blood
type
SECONDARY
unit Of Measure
cells/kg

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

Preserved source evidence · Not medical advice