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NCT02184195 · OUTCOME

Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy · Source last updated 2023-09-13

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
At 16 weeks

What was measured

Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.

Analysis population: Intention to treat (ITT): All randomised patients

Groups in this outcome

Olaparib 300 mg Twice Daily (bd)

Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

Placebo

Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.

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

Analysis denominator · Participants

GroupSource count
Olaparib 300 mg Twice Daily (bd)92
Placebo62

Reported measurements

Yes
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)51Not reportedNot reportedNot reportedNot reported
Placebo24Not reportedNot reportedNot reportedNot reported
No
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)34Not reportedNot reportedNot reportedNot reported
Placebo34Not reportedNot reportedNot reportedNot reported
Not evaluable/missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 300 mg Twice Daily (bd)7Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        51
      2. group Id
        OG001
        value
        24
    title
    Yes
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        34
      2. group Id
        OG001
        value
        34
    title
    No
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
    title
    Not evaluable/missing
denoms
  1. counts
    1. group Id
      OG000
      value
      92
    2. group Id
      OG001
      value
      62
    units
    Participants
description
Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.
groups
  1. description
    Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
    id
    OG000
    title
    Olaparib 300 mg Twice Daily (bd)
  2. description
    Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Intention to treat (ITT): All randomised patients
reporting Status
POSTED
time Frame
At 16 weeks
title
Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice