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NCT01696084 · OUTCOME

Overall Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization to death from any cause

What was measured

Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (CPX-351)9.56Not reported6.6011.86Not reported
Arm B (7+3)5.95Not reported4.997.75Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.60
        upper Limit
        11.86
        value
        9.56
      2. group Id
        OG001
        lower Limit
        4.99
        upper Limit
        7.75
        value
        5.95
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      156
    units
    Participants
description
Overall survival was measured from the date of randomization to death from any cause, subjects not known to have died by the last follow-up were censored on the date they were last known to be alive.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Intent-to-Treat (ITT) Population: All participants randomized in the study.
reporting Status
POSTED
time Frame
From the date of randomization to death from any cause
title
Overall Survival
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice