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NCT03531840 · OUTCOME

Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response.

Olaparib in People With 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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
6 months after enrollment of last patient

What was measured

Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.

Analysis population: Per protocol, this outcome measure was only assessed in participants in Comparison Group 3.

Groups in this outcome

Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations

Participants With no tumor tissue available for somatic mutation

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

Analysis denominator · Participants

GroupSource count
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations8

Reported measurements

Partial Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations0Not reportedNot reportedNot reportedNot reported
Complete Response
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
Percentage of subjects with neither germline DNA repair mutations nor somatic BAP1 mutations who experienced partial or complete response.Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, and the Malignant Pleural Mesothelioma (MPM) criteria. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions.
groups
  1. description
    Participants With no tumor tissue available for somatic mutation
    id
    OG000
    title
    Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
param Type
NUMBER
population Description
Per protocol, this outcome measure was only assessed in participants in Comparison Group 3.
reporting Status
POSTED
time Frame
6 months after enrollment of last patient
title
Percentage of Subjects With Neither Germline Deoxyribonuclecic Acid (DNA) Repair Mutations Nor Somatic Breast Cancer Type 1 Associated Protein-1 (BAP1) Mutations Who Experienced Partial or Complete Response.
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice