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NCT02860286 · OUTCOME

Part 1 and 2: Overall Survival (OS)

Study of the EZH2 Inhibitor Tazemetostat in Malignant Mesothelioma · Source last updated 2021-04-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Weeks
Interval / dispersion
Inter-Quartile Range
Time frame
The patients were assessed for PFS for up to 24 weeks

What was measured

OS was analyzed and listed for the ITT population. Subjects who have not died were censored at the date of last contact which was identified from a visit date, study assessment (physical examination, vital signs, ECOG performance status, electrocardiogram \[ECG\], study drug record, radiological evaluation), AE, medication, or disposition information. OS was calculated using the Kaplan-Meier method. OS at 12 and 24 weeks along with the associated 2-sided 95% CIs were provided. Median OS, first and third quartiles and associated 95% 2-sided CIs were provided.

Groups in this outcome

Part 1

Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status

Part 2

Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma

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

Analysis denominator · Participants

GroupSource count
Part 113
Part 261

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Part 129.0Not reported16.3139.7Not reported
Part 241.0Not reported1.6120.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.3
        upper Limit
        139.7
        value
        29.0
      2. group Id
        OG001
        lower Limit
        1.6
        upper Limit
        120.9
        value
        41.0
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      61
    units
    Participants
description
OS was analyzed and listed for the ITT population. Subjects who have not died were censored at the date of last contact which was identified from a visit date, study assessment (physical examination, vital signs, ECOG performance status, electrocardiogram \[ECG\], study drug record, radiological evaluation), AE, medication, or disposition information. OS was calculated using the Kaplan-Meier method. OS at 12 and 24 weeks along with the associated 2-sided 95% CIs were provided. Median OS, first and third quartiles and associated 95% 2-sided CIs were provided.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status
    id
    OG000
    title
    Part 1
  2. description
    Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma
    id
    OG001
    title
    Part 2
param Type
MEDIAN
reporting Status
POSTED
time Frame
The patients were assessed for PFS for up to 24 weeks
title
Part 1 and 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice