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NCT02610140 · OUTCOME

Number of Deaths

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
Number of Deaths
Interval / dispersion
Not reported
Time frame
Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

What was measured

TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018.

Analysis population: The secondary efficacy analysis (TEAEs) was performed in the safety analysis set (SAF).

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 Ravtansine163
Vinorelbine72

Reported measurements

Source class 1
Values in Number of Deaths · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anetumab Ravtansine10Not reportedNot reportedNot reportedNot reported
Vinorelbine1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      163
    2. group Id
      OG001
      value
      72
    units
    Participants
description
TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018.
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 (TEAEs) was performed in the safety analysis set (SAF).
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
Number of Deaths
type
SECONDARY
unit Of Measure
Number of Deaths

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

Preserved source evidence · Not medical advice