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NCT00628251 · OUTCOME

Progression Free Survival (PFS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)

What was measured

PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd6.5Not reported5.510.1Not reported
Olaparib 400 mg bd8.8Not reported5.49.2Not reported
Liposomal Doxorubicin7.1Not reported3.710.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.5
        upper Limit
        10.1
        value
        6.5
      2. group Id
        OG001
        lower Limit
        5.4
        upper Limit
        9.2
        value
        8.8
      3. group Id
        OG002
        lower Limit
        3.7
        upper Limit
        10.7
        value
        7.1
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      33
    units
    Participants
description
PFS was defined as the time to progression from the date of randomisation until the date of radiological assessment of progression per RECIST criteria or death (by any cause in the absence of progression)
dispersion Type
95% Confidence Interval
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
MEDIAN
reporting Status
POSTED
time Frame
Tumour assessment was to be assessed at screening, every 8 weeks during the study and at the withdrawal visit, up to 56 weeks. (Data cut-off for primary analysis of PFS: 15 September 2009)
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice