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NCT02610140 · OUTCOME

Duration of Response (DOR)

Phase II Anetumab Ravtansine as 2nd Line Treatment for Malignant Pleural Mesothelioma (MPM) · Source last updated 2020-11-04

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 approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

What was measured

DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.

Analysis population: The secondary efficacy analysis (DOR) was performed in the ITT (Intent-to-treat) analysis set.

Groups in this outcome

Anetumab Ravtansine

Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour

Vinorelbine

Active comparator: 30 mg/m\^2 once weekly

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

Analysis denominator · Participants

GroupSource count
Anetumab Ravtansine166
Vinorelbine82

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Anetumab Ravtansine7.4Not reported6.0NANA = value cannot be estimated due to censored data
Vinorelbine6.7Not reported3.010.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = value cannot be estimated due to censored data
        group Id
        OG000
        lower Limit
        6.0
        upper Limit
        NA
        value
        7.4
      2. group Id
        OG001
        lower Limit
        3.0
        upper Limit
        10.3
        value
        6.7
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      82
    units
    Participants
description
DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Test drug: 6.5 mg/kg every 3 weeks; Intravenous (IV) infusion over 1 hour
    id
    OG000
    title
    Anetumab Ravtansine
  2. description
    Active comparator: 30 mg/m\^2 once weekly
    id
    OG001
    title
    Vinorelbine
param Type
MEDIAN
population Description
The secondary efficacy analysis (DOR) was performed in the ITT (Intent-to-treat) analysis set.
reporting Status
POSTED
time Frame
Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice