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NCT02610140 · OUTCOME

Percentage of Participants With Confirmed Improvement of Pain

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

What was measured

Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain.

Analysis population: The secondary efficacy analysis 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 Ravtansine40.4Not reported30.950.5Not reported
Vinorelbine32.7Not reported19.947.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -9.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.68
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.214
    param Type
    Difference (%) improvement rate of pain
    param Value
    6.64
    statistical Comment
    1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    -9.40
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    22.68
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.214
    param Type
    Difference (%) improvement rate of pain
    param Value
    6.64
    statistical Comment
    1-sided Cochran-Mantel-Haenszel test, stratified by TTP on 1st line treatment
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.9
        upper Limit
        50.5
        value
        40.4
      2. group Id
        OG001
        lower Limit
        19.9
        upper Limit
        47.5
        value
        32.7
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      82
    units
    Participants
description
Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the "pain at its worst" item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain.
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 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
Percentage of Participants With Confirmed Improvement of Pain
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice