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NCT01207388 · OUTCOME

100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL) · Source last updated 2020-02-10

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
100 days after HSCT, as of the data cut-off date of 05 August 2015

What was measured

The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.

Analysis population: Full analysis set participants who underwent HSCT prior to relapse (hematological or extramedullary) excluding Philadelphia-positive participants

Groups in this outcome

Blinatumomab

Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.

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

Analysis denominator · Participants

GroupSource count
Blinatumomab74

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab7Not reported315Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3
        upper Limit
        15
        value
        7
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    units
    Participants
description
The mortality rate within 100 days after allogeneic HSCT was defined as the Kaplan-Meier estimate of the percentage of participants dying within 100 days after the day of the first allogeneic HSCT.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
NUMBER
population Description
Full analysis set participants who underwent HSCT prior to relapse (hematological or extramedullary) excluding Philadelphia-positive participants
reporting Status
POSTED
time Frame
100 days after HSCT, as of the data cut-off date of 05 August 2015
title
100-Day Mortality After Allogeneic Hematopoietic Stem Cell Transplant
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice