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NCT02113982 · OUTCOME

OS in First-line BPDCN, R/R BPDCN and AML

Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia · Source last updated 2024-08-01

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 first infusion to treatment discontinuation when survival is assessed every 90 days up to end of follow-up or death, up to 5 years

What was measured

Overall survival (months) defined as the time from the date of first infusion of Tagraxofusp to the date of death from any cause

Analysis population: Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML

Groups in this outcome

First-line BPDCN

First-line BPDCN patients enrolled across stages

R/R BPDCN

R/R BPDCN patients enrolled across stages

Acute Myeloid Leukemia

AML patients enrolled in stages 1 and 2

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

Analysis denominator · Participants

GroupSource count
First-line BPDCN65
R/R BPDCN19
Acute Myeloid Leukemia36

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
First-line BPDCN15.8Not reported9.725.8Not reported
R/R BPDCN8.2Not reported4.111.9Not reported
Acute Myeloid Leukemia5.7Not reportedNANArange 0.49-24 months. 95% CI not estimable
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.7
        upper Limit
        25.8
        value
        15.8
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        11.9
        value
        8.2
      3. comment
        range 0.49-24 months. 95% CI not estimable
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        5.7
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      36
    units
    Participants
description
Overall survival (months) defined as the time from the date of first infusion of Tagraxofusp to the date of death from any cause
dispersion Type
95% Confidence Interval
groups
  1. description
    First-line BPDCN patients enrolled across stages
    id
    OG000
    title
    First-line BPDCN
  2. description
    R/R BPDCN patients enrolled across stages
    id
    OG001
    title
    R/R BPDCN
  3. description
    AML patients enrolled in stages 1 and 2
    id
    OG002
    title
    Acute Myeloid Leukemia
param Type
MEDIAN
population Description
Efficacy population including evaluable patients treated at 12 μg/kg/day in the first-line BPDCN, R/R BPDCN and AML
reporting Status
POSTED
time Frame
From first infusion to treatment discontinuation when survival is assessed every 90 days up to end of follow-up or death, up to 5 years
title
OS in First-line BPDCN, R/R BPDCN and AML
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice