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NCT01869777 · OUTCOME

Number of Participants With Bone Marrow Response

Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia · Source last updated 2020-08-13

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
14 days

What was measured

Logistic regression will be used to analyze the significant association between standardized phase angle and marrow response at 14-day bone marrow biopsy to show the odds of having 14-day residual disease (presence cancer cells remaining after treatment) and non-residual disease (no cancer cells remaining after treatment). (14 day bone marrow response is defined as hypoplastic marrow with less than 20% cellularity and 5% blasts. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count \>1000, platelet count \>100,000 and freedom from red cell transfusions).

Analysis population: 14 participants excluded in analysis due to 14-day bone marrow data not available.

Groups in this outcome

Diagnostic (Bioelectric Impedance Analysis)

Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.). bioelectric impedance analysis: Undergo bioelectric impedance analysis

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

Analysis denominator · Participants

GroupSource count
Diagnostic (Bioelectric Impedance Analysis)87

Reported measurements

Source class 1

Residual disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Diagnostic (Bioelectric Impedance Analysis)47Not reportedNot reportedNot reportedNot reported

No residual disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Diagnostic (Bioelectric Impedance Analysis)40Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47
      title
      Residual disease
    2. measurements
      1. group Id
        OG000
        value
        40
      title
      No residual disease
denoms
  1. counts
    1. group Id
      OG000
      value
      87
    units
    Participants
description
Logistic regression will be used to analyze the significant association between standardized phase angle and marrow response at 14-day bone marrow biopsy to show the odds of having 14-day residual disease (presence cancer cells remaining after treatment) and non-residual disease (no cancer cells remaining after treatment). (14 day bone marrow response is defined as hypoplastic marrow with less than 20% cellularity and 5% blasts. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count \>1000, platelet count \>100,000 and freedom from red cell transfusions).
groups
  1. description
    Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement just prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, PICC line placement, etc.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
    id
    OG000
    title
    Diagnostic (Bioelectric Impedance Analysis)
param Type
COUNT_OF_PARTICIPANTS
population Description
14 participants excluded in analysis due to 14-day bone marrow data not available.
reporting Status
POSTED
time Frame
14 days
title
Number of Participants With Bone Marrow Response
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice