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NCT03531840 · OUTCOME

Number of Participants With an Objective 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 months after enrollment of last patient

What was measured

Number of participants overall 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: Data is grouped as specified per protocol.

Groups in this outcome

Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes

Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes

Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations

Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations

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

Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations

Participants Not Classified Under Comparison Groups

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 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes5
Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations6
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations8
Participants Not Classified Under Comparison Groups4

Reported measurements

Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes1Not reportedNot reportedNot reportedNot reported
Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations0Not reportedNot reportedNot reportedNot reported
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations0Not reportedNot reportedNot reportedNot reported
Participants Not Classified Under Comparison Groups0Not reportedNot reportedNot reportedNot reported
Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes0Not reportedNot reportedNot reportedNot reported
Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations0Not reportedNot reportedNot reportedNot reported
Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations0Not reportedNot reportedNot reportedNot reported
Participants Not Classified Under Comparison Groups0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Partial Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
    title
    Complete Response
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      4
    units
    Participants
description
Number of participants overall 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 a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
    id
    OG000
    title
    Comparison Group 1:Participants With a Germline Mutation in Deoxyribonucleic Acid (DNA) Repair Genes
  2. description
    Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
    id
    OG001
    title
    Comparison Group 2: Participants With BRCA1 Associated Protein-1 (BAP1) Somatic Mutations
  3. description
    Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
    id
    OG002
    title
    Comparison Group 3: Participants With Neither Germline Mutations Nor BAP 1 Somatic Mutations
  4. description
    Participants with no tumor tissue available for somatic mutation
    id
    OG003
    title
    Participants Not Classified Under Comparison Groups
param Type
COUNT_OF_PARTICIPANTS
population Description
Data is grouped as specified per protocol.
reporting Status
POSTED
time Frame
6 months after enrollment of last patient
title
Number of Participants With an Objective Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice