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NCT00628251 · OUTCOME

Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)

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
COUNT_OF_PARTICIPANTS
Unit
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

Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.

Analysis population: Evaluable for FACT-O at baseline

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

Improved
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd3Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd6Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin1Not reportedNot reportedNot reportedNot reported
No Change
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd14Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd11Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin11Not reportedNot reportedNot reportedNot reported
Worsened
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd3Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd5Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin7Not reportedNot reportedNot reportedNot reported
Non-evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd5Not reportedNot reportedNot reportedNot reported
Olaparib 400 mg bd7Not reportedNot reportedNot reportedNot reported
Liposomal Doxorubicin8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
    title
    Improved
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        11
    title
    No Change
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        7
    title
    Worsened
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        8
    title
    Non-evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      33
    units
    Participants
description
Best HRQoL response using the total FACT-O endpoint. Improvement was defined as a change from baseline of greater than or equal to +9.
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
COUNT_OF_PARTICIPANTS
population Description
Evaluable for FACT-O at baseline
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
Best QoL Response for Total Functional Analysis of Cancer Therapy - Ovarian (FACT-O)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice