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NCT02689219 · OUTCOME

Progression Free Survival

Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors · Source last updated 2019-12-10

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
Up to 2 years

What was measured

Duration of time from the start of treatment to time of documented progression or death. Patients who did not progress or die were censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.

Analysis population: All patients who received at least one dose of study medication.

Groups in this outcome

CD30 Negative/Unknown

Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.

CD30 Positive

Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.

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

Analysis denominator · Participants

GroupSource count
CD30 Negative/Unknown11
CD30 Positive7

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CD30 Negative/Unknown1.38Not reported0.002.07Not reported
CD30 Positive1.15Not reported0.922.11Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.00
        upper Limit
        2.07
        value
        1.38
      2. group Id
        OG001
        lower Limit
        0.92
        upper Limit
        2.11
        value
        1.15
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Duration of time from the start of treatment to time of documented progression or death. Patients who did not progress or die were censored on their last evaluation date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Brentuximab Vedotin 1.8 mg/kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Negative/Unknown cohort.
    id
    OG000
    title
    CD30 Negative/Unknown
  2. description
    Brentuximab Vedotin 1.8 mg/ kg (1.2 mg/kg in patients with grade 2 peripheral neuropathy at enrollment) administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle for CD30 Positive cohort.
    id
    OG001
    title
    CD30 Positive
param Type
MEDIAN
population Description
All patients who received at least one dose of study medication.
reporting Status
POSTED
time Frame
Up to 2 years
title
Progression Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice