Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02610140 · OUTCOME

Time to Worsening of Symptoms Characteristic of Mesothelioma

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
days
Interval / dispersion
95% Confidence Interval
Time frame
up to approx. 30 months (data cut-off: 31-May-2017)

What was measured

Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS.

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 days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Anetumab RavtansineNANot reportedNANAvalue cannot be estimated due to censored data
VinorelbineNANot reportedNANAvalue cannot be estimated due to censored data

Source statistical analyses

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

  1. ci Lower Limit
    0.386
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.779
    group Description
    Anetumab ravtansine versus vinorelbine
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.313747
    param Type
    Hazard Ratio (HR)
    param Value
    0.829
    statistical Comment
    one-sided log-rank test stratified by time to progression (TTP) on first line treatment
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.386
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.779
    group Description
    Anetumab ravtansine versus vinorelbine
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.313747
    param Type
    Hazard Ratio (HR)
    param Value
    0.829
    statistical Comment
    one-sided log-rank test stratified by time to progression (TTP) on first line treatment
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        value cannot be estimated due to censored data
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        value cannot be estimated due to censored data
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      82
    units
    Participants
description
Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS.
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 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)
title
Time to Worsening of Symptoms Characteristic of Mesothelioma
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice