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NCT00628251 · OUTCOME

Confirmed RECIST Response and/or CA-125 Response

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

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
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

What was measured

The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.

Groups in this outcome

Olaparib 200 mg bd

Olaparib (AZD2281) 200 mg oral capsules twice daily

Olaparib 400 mg bd

Olaparib (AZD2281) 400 mg oral capsules twice daily

Liposomal Doxorubicin

Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks

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 200 mg bd32
Olaparib 400 mg bd32
Liposomal Doxorubicin33

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd37.5Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd59.4Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin39.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        37.5
      2. group Id
        OG001
        value
        59.4
      3. group Id
        OG002
        value
        39.4
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      33
    units
    Participants
description
The percentage of patients reporting a RECIST confirmed response and/or a CA-125 response (in the absence of progression). A CA-125 response was defined as a confirmed greater or equal to 50% reduction in CA-125.
groups
  1. description
    Olaparib (AZD2281) 200 mg oral capsules twice daily
    id
    OG000
    title
    Olaparib 200 mg bd
  2. description
    Olaparib (AZD2281) 400 mg oral capsules twice daily
    id
    OG001
    title
    Olaparib 400 mg bd
  3. description
    Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
    id
    OG002
    title
    Liposomal Doxorubicin
param Type
NUMBER
reporting Status
POSTED
time Frame
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
title
Confirmed RECIST Response and/or CA-125 Response
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice