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NCT02610140 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause.

What was measured

A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. 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 (ORR) 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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Anetumab Ravtansine8.4Not reported4.713.7Not reported
Vinorelbine6.1Not reported2.013.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.7
        upper Limit
        13.7
        value
        8.4
      2. group Id
        OG001
        lower Limit
        2.0
        upper Limit
        13.7
        value
        6.1
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      82
    units
    Participants
description
A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. 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
NUMBER
population Description
The secondary efficacy analysis (ORR) was performed in the ITT (Intent-to-treat) analysis set.
reporting Status
POSTED
time Frame
up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause.
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice