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NCT01696084 · OUTCOME

Proportion of Subjects Receiving a Stem Cell Transplant

Phase III Study of CPX-351 Versus 7+3 in Patients 60-75 Years Old With Untreated High Risk (Secondary) Acute Myeloid Leukemia · Source last updated 2020-08-10

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
Post Induction

What was measured

The number and percentage of subjects transferred for HSCT after induction treatment was recorded.

Analysis population: Intent-to-Treat (ITT) Population: All participants randomized in the study.

Groups in this outcome

Arm A (CPX-351)

Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.

Arm B (7+3)

Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.

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

Analysis denominator · Participants

GroupSource count
Arm A (CPX-351)153
Arm B (7+3)156

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (CPX-351)52Not reportedNot reportedNot reportedNot reported
Arm B (7+3)39Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52
      2. group Id
        OG001
        value
        39
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      156
    units
    Participants
description
The number and percentage of subjects transferred for HSCT after induction treatment was recorded.
groups
  1. description
    Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with CPX-351. The number of inductions and consolidations a subject received depended on response.
    id
    OG000
    title
    Arm A (CPX-351)
  2. description
    Subjects are eligible to receive up to 2 inductions and up to 2 consolidations with cytarabine and daunorubicin given as a 7 + 3, or 5 days of continuous infusion of cytarabine and 2 days of daunorubicin (5+2, second induction, consolidation courses) therapy. The number of inductions and consolidations a subject received depended on response.
    id
    OG001
    title
    Arm B (7+3)
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
reporting Status
POSTED
time Frame
Post Induction
title
Proportion of Subjects Receiving a Stem Cell Transplant
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice