Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02610140 · OUTCOME

Progression-free Survival (PFS), [95% CI]

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
From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017)

What was measured

Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.

Analysis population: The primary efficacy analysis (PFS) 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 Ravtansine4.3Not reported4.15.5Not reported
Vinorelbine4.5Not reported4.15.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.850
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1,738
    estimate Comment
    Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.
    group Description
    PFS anetumab ravtansine / vinorelbine
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.859125
    p Value Comment
    1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.
    param Type
    Hazard Ratio (HR)
    param Value
    1.215
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.850
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1,738
    estimate Comment
    Hazard ratio (anetumab ravtansine / vinorelbine) was estimated using Cox proportional hazards models with Wald CIs, stratified by Time to progression (TTP) on 1st line treatment.
    group Description
    PFS anetumab ravtansine / vinorelbine
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.859125
    p Value Comment
    1-sided p-value from log-rank test (stratified by TTP on 1st line treatment). P-value is calculated based on alpha level 0.0125.
    param Type
    Hazard Ratio (HR)
    param Value
    1.215
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        5.5
        value
        4.3
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        5.8
        value
        4.5
denoms
  1. counts
    1. group Id
      OG000
      value
      166
    2. group Id
      OG001
      value
      82
    units
    Participants
description
Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period.
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 primary efficacy analysis (PFS) was performed in the ITT (Intent-to-treat) analysis set.
reporting Status
POSTED
time Frame
From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017)
title
Progression-free Survival (PFS), [95% CI]
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice