Skip to content
← Full study record

NCT02000427 · OUTCOME

Overall Survival

Blinatumomab in Adults With Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukemia · Source last updated 2024-05-28

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 dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.

What was measured

Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up. Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive.

Analysis population: All participants who received an infusion of blinatumomab

Groups in this outcome

Blinatumomab

Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent 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
Blinatumomab45

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Blinatumomab7.1Not reported5.6NACould not be estimated due to the low number of events at the time of analysis
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Could not be estimated due to the low number of events at the time of analysis
        group Id
        OG000
        lower Limit
        5.6
        upper Limit
        NA
        value
        7.1
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
Overall survival was assessed from the date the participant received the first infusion of blinatumomab until death from any cause or the date of the last follow-up. Participants still alive at the data cut-off date were censored on the last documented visit date or the date of the last contact when the patient was last known to have been alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for 2 cycles. Participants who achieved a complete remission or complete remission with partial or incomplete hematologic recovery within 2 induction cycles of treatment could receive up to 3 additional consolidation cycles of blinatumomab. The initial dose was 9 μg/day for the first 7 days of treatment, increased to 28 μg/day starting on day 8 and for all subsequent cycles of treatment.
    id
    OG000
    title
    Blinatumomab
param Type
MEDIAN
population Description
All participants who received an infusion of blinatumomab
reporting Status
POSTED
time Frame
From first dose of blinatumomab until the data cut-off date; median observation time was 8.8 months.
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice