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NCT00738582 · OUTCOME

Overall Survival (OS)

An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma · Source last updated 2022-09-22

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 the date of first dose to the date of death, up to approximately 5 years

What was measured

OS was defined as the time from the date of the first dose of amatuximab to the date of death.

Analysis population: Safety population consisted of all participants who received at least 1 dose of amatuximab.

Groups in this outcome

All Participants

Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Participants89

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
All Participants14.8Not reported12.418.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.4
        upper Limit
        18.8
        value
        14.8
denoms
  1. counts
    1. group Id
      OG000
      value
      89
    units
    Participants
description
OS was defined as the time from the date of the first dose of amatuximab to the date of death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received amatuximab 5 mg/kg, IV infusion on Days 1 and 8 with pemetrexed 500 mg/m\^2, IV infusion on Day 1 and cisplatin 75 mg/ m\^2, IV infusion on Day 1 of each 21-day cycle for approximately 6 cycles during combination therapy. Participants who completed 6 cycles of combination therapy or who discontinued chemotherapy because of intolerable toxicity continued receiving single agent amatuximab 5 mg/kg, IV infusion on Day 1 and 8 of each 21-day cycle until disease progression or death for all subsequent cycles (up to 52 Cycles \[Cycle length is 21 days\]).
    id
    OG000
    title
    All Participants
param Type
MEDIAN
population Description
Safety population consisted of all participants who received at least 1 dose of amatuximab.
reporting Status
POSTED
time Frame
From the date of first dose to the date of death, up to approximately 5 years
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice