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NCT02104427 · OUTCOME

the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF

PD and Safety of TG-0054 Combined With G-CSF in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · 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/µL
Interval / dispersion
Full Range
Time frame
Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)

What was measured

determine circulating CD34+ cell counts in peripheral blood

Analysis population: There were 5 patients who achived target number of CD34+ cells (\>=5.0\*10\^6 cells/kg) within two leukapheresis sessions and therefore didn't undergo addtional sessions. Among 7 patients who undergone 6 sessions, there were 1 patient didn't collect blood sample at 4h, 6h post-infusion and post-leukapheresis, and 1 patient 6h post-infusion not done.

Groups in this outcome

Pre-dose

Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-dose timepoint

4h Post-infusion

Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 4h post-infusion timepoint

6h Post-infusion

Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 6h post-infusion timepoint

Pre-leukapheresis

Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-leukapheresis timepoint

Post-leukapheresis

Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Post-leukapheresis timepoint

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

Analysis denominator · Participants

GroupSource count
Pre-dose12
4h Post-infusion12
6h Post-infusion12
Pre-leukapheresis12
Post-leukapheresis12

Reported measurements

Day 5 (1st leukapheresis session)

Analysis denominator · Participants

GroupSource count
Pre-dose12
4h Post-infusion12
6h Post-infusion12
Pre-leukapheresis12
Post-leukapheresis12
Values in cells/µL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pre-dose32.50Not reported1.00123.00Not reported
4h Post-infusion43.50Not reported0.00141.00Not reported
6h Post-infusion42.00Not reported1.00122.00Not reported
Pre-leukapheresis60.50Not reported1.00206.00Not reported
Post-leukapheresis35.50Not reported3.00119.00Not reported
Day 6 (2nd leukapheresis session)

Analysis denominator · Participants

GroupSource count
Pre-dose7
4h Post-infusion6
6h Post-infusion5
Pre-leukapheresis7
Post-leukapheresis6
Values in cells/µL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pre-dose16.00Not reported1.0059.50Not reported
4h Post-infusion28.00Not reported14.0045.00Not reported
6h Post-infusion20.00Not reported0.0045.00Not reported
Pre-leukapheresis34.00Not reported2.0070.00Not reported
Post-leukapheresis21.00Not reported16.0045.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        123.00
        value
        32.50
      2. group Id
        OG001
        lower Limit
        0.00
        upper Limit
        141.00
        value
        43.50
      3. group Id
        OG002
        lower Limit
        1.00
        upper Limit
        122.00
        value
        42.00
      4. group Id
        OG003
        lower Limit
        1.00
        upper Limit
        206.00
        value
        60.50
      5. group Id
        OG004
        lower Limit
        3.00
        upper Limit
        119.00
        value
        35.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        12
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        12
      5. group Id
        OG004
        value
        12
      units
      Participants
    title
    Day 5 (1st leukapheresis session)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.00
        upper Limit
        59.50
        value
        16.00
      2. group Id
        OG001
        lower Limit
        14.00
        upper Limit
        45.00
        value
        28.00
      3. group Id
        OG002
        lower Limit
        0.00
        upper Limit
        45.00
        value
        20.00
      4. group Id
        OG003
        lower Limit
        2.00
        upper Limit
        70.00
        value
        34.00
      5. group Id
        OG004
        lower Limit
        16.00
        upper Limit
        45.00
        value
        21.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        7
      5. group Id
        OG004
        value
        6
      units
      Participants
    title
    Day 6 (2nd leukapheresis session)
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      12
    4. group Id
      OG003
      value
      12
    5. group Id
      OG004
      value
      12
    units
    Participants
description
determine circulating CD34+ cell counts in peripheral blood
dispersion Type
Full Range
groups
  1. description
    Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-dose timepoint
    id
    OG000
    title
    Pre-dose
  2. description
    Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 4h post-infusion timepoint
    id
    OG001
    title
    4h Post-infusion
  3. description
    Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at 6h post-infusion timepoint
    id
    OG002
    title
    6h Post-infusion
  4. description
    Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Pre-leukapheresis timepoint
    id
    OG003
    title
    Pre-leukapheresis
  5. description
    Circulating CD34+ Cell Count (cells/µL) in Peripheral Blood at Post-leukapheresis timepoint
    id
    OG004
    title
    Post-leukapheresis
param Type
MEDIAN
population Description
There were 5 patients who achived target number of CD34+ cells (\>=5.0\*10\^6 cells/kg) within two leukapheresis sessions and therefore didn't undergo addtional sessions. Among 7 patients who undergone 6 sessions, there were 1 patient didn't collect blood sample at 4h, 6h post-infusion and post-leukapheresis, and 1 patient 6h post-infusion not done.
reporting Status
POSTED
time Frame
Day 5 (1st leukapheresis session) to Day 6 (2nd leukapheresis session)
title
the Pharmacodynamics (PD) Following Treatment With TG-0054 When Combined With G-CSF
type
SECONDARY
unit Of Measure
cells/µL

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Preserved source evidence · Not medical advice