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NCT02610140 · OUTCOME

Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)

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
Not reported
Time frame
Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).

What was measured

TEAEs were defined as all AEs starting or worsening within the treatment period.

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

Any TEAE
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anetumab Ravtansine99.4Not reportedNot reportedNot reportedNot reported
Vinorelbine98.6Not reportedNot reportedNot reportedNot reported
Any study drug-related TEAE
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anetumab Ravtansine88.3Not reportedNot reportedNot reportedNot reported
Vinorelbine90.3Not reportedNot reportedNot reportedNot reported
Treatment-emergent serious adverse events (TESAEs)
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anetumab Ravtansine34.4Not reportedNot reportedNot reportedNot reported
Vinorelbine34.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        99.4
      2. group Id
        OG001
        value
        98.6
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        88.3
      2. group Id
        OG001
        value
        90.3
    title
    Any study drug-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        34.4
      2. group Id
        OG001
        value
        34.7
    title
    Treatment-emergent serious adverse events (TESAEs)
denoms
  1. counts
    1. group Id
      OG000
      value
      163
    2. group Id
      OG001
      value
      72
    units
    Participants
description
TEAEs were defined as all AEs starting or worsening within the treatment period.
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. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).
title
Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice