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NCT01018979 · OUTCOME

Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.

Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-05-11

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

Measure
MEAN
Unit
fold
Interval / dispersion
Standard Deviation
Time frame
Baseline, 3 hours and 6 hours after infusion

Groups in this outcome

Multiple Myeloma (MM)

7 patients with MM were enrolled.

Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)

10 patients and 2 patients with NHL and HD were enrolled, respectively.

All Patients

All patents = MM + NHL + HD

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

Analysis denominator · Participants

GroupSource count
Multiple Myeloma (MM)7
Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)12
All Patients19

Reported measurements

Fold increase (3 hours after infusion)
Values in fold · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM)7.05.9Not reportedNot reportedNot reported
Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)6.16.1Not reportedNot reportedNot reported
All Patients6.45.9Not reportedNot reportedNot reported
Fold increase (6 hours after infusion)
Values in fold · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM)7.87.2Not reportedNot reportedNot reported
Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)7.810.4Not reportedNot reportedNot reported
All Patients7.89.1Not reportedNot reportedNot reported
Fold increase (Maximum increase)
Values in fold · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Multiple Myeloma (MM)9.37.5Not reportedNot reportedNot reported
Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)10.38.9Not reportedNot reportedNot reported
All Patients10.08.4Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Description
    Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.023
    p Value Comment
    P values less than 0.05 are considered statistically significant in this study.
    statistical Method
    t-test, 2 sided
  2. ci Num Sides
    TWO_SIDED
    group Description
    Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.038
    p Value Comment
    P values less than 0.05 are considered statistically significant in this study.
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.023
    p Value Comment
    P values less than 0.05 are considered statistically significant in this study.
    statistical Method
    t-test, 2 sided
  2. ci Num Sides
    TWO_SIDED
    group Description
    Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.038
    p Value Comment
    P values less than 0.05 are considered statistically significant in this study.
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5.9
        value
        7.0
      2. group Id
        OG001
        spread
        6.1
        value
        6.1
      3. group Id
        OG002
        spread
        5.9
        value
        6.4
    title
    Fold increase (3 hours after infusion)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.2
        value
        7.8
      2. group Id
        OG001
        spread
        10.4
        value
        7.8
      3. group Id
        OG002
        spread
        9.1
        value
        7.8
    title
    Fold increase (6 hours after infusion)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.5
        value
        9.3
      2. group Id
        OG001
        spread
        8.9
        value
        10.3
      3. group Id
        OG002
        spread
        8.4
        value
        10.0
    title
    Fold increase (Maximum increase)
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      12
    3. group Id
      OG002
      value
      19
    units
    Participants
dispersion Type
Standard Deviation
groups
  1. description
    7 patients with MM were enrolled.
    id
    OG000
    title
    Multiple Myeloma (MM)
  2. description
    10 patients and 2 patients with NHL and HD were enrolled, respectively.
    id
    OG001
    title
    Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)
  3. description
    All patents = MM + NHL + HD
    id
    OG002
    title
    All Patients
param Type
MEAN
reporting Status
POSTED
time Frame
Baseline, 3 hours and 6 hours after infusion
title
Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
type
SECONDARY
unit Of Measure
fold

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

Preserved source evidence · Not medical advice