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NCT01805037 · OUTCOME

Percentage of Participants Alive at 2 Years (Overall Survival)

Brentuximab Vedotin + Rituximab as Frontline Therapy for Pts w/ CD30+ and/or EBV+ Lymphomas · Source last updated 2021-09-01

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

Measure
NUMBER
Unit
percent of participants
Interval / dispersion
90% Confidence Interval
Time frame
From start of treatment to 2 years post treatment discontinuation

What was measured

Overall survival (OS) will be measured from treatment initiation until death from any cause for up to 1 year post-treatment discontinuation. Overall survival is defined as the duration of time from start of treatment to time of death. All patients who have had at least one dose of study treatment will be evaluable for OS. OS will be reported as percentage of participants alive at 2 years post treatment discontinuation, with censoring of patients who are lost to follow-up.

Analysis population: One patient was censored from overall survival because they were lost to follow-up.

Groups in this outcome

Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)

Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.

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

Analysis denominator · Participants

GroupSource count
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)19

Reported measurements

Source class 1
Values in percent of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)90Not reported77100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77
        upper Limit
        100
        value
        90
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Overall survival (OS) will be measured from treatment initiation until death from any cause for up to 1 year post-treatment discontinuation. Overall survival is defined as the duration of time from start of treatment to time of death. All patients who have had at least one dose of study treatment will be evaluable for OS. OS will be reported as percentage of participants alive at 2 years post treatment discontinuation, with censoring of patients who are lost to follow-up.
dispersion Type
90% Confidence Interval
groups
  1. description
    Induction: * Brentuximab vedotin 1.2 mg/kg IV infusion over 30 minutes, weekly x 3 (1 cycle = 4 weeks * Rituximab 375 mg/m2 IV infusion per standard protocol, once weekly for 4 weeks (1 cycle = 4 weeks) Consolidation (optional): Identical to Induction. Maintenance: * Brentuximab vedotin 1.8 mg/kg IV infusion over 30 minutes once every 3 weeks (1 cycle = 3 weeks), for a total of one year from the first induction dose or until progression of disease. * Rituximab 375 mg/m2 IV infusion per standard protocol, once every 6 weeks for a total of one year from the first induction dose or until progression of disease.
    id
    OG000
    title
    Brentuximb Vedotin Dose Level 1 (1.2 mg/kg)
param Type
NUMBER
population Description
One patient was censored from overall survival because they were lost to follow-up.
reporting Status
POSTED
time Frame
From start of treatment to 2 years post treatment discontinuation
title
Percentage of Participants Alive at 2 Years (Overall Survival)
type
SECONDARY
unit Of Measure
percent of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice