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NCT01891344 · OUTCOME

Overall Survival (Part 2 of Study)

A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) · Source last updated 2023-06-12

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
All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years.

What was measured

Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.

Analysis population: Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib.

Groups in this outcome

Part 2: tBRCA

Patients with a deleterious BRCA mutation detected in their tumor.

Part 2: Non-tBRCA LOH+

Patients without a BRCA mutation in their tumor, but have high LOH.

Part 2: Non-tBRCA LOH-

Patients without a BRCA mutation in their tumor, but have low LOH.

Part 2: Non-tBRCA LOH Unknown

Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).

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

Analysis denominator · Participants

GroupSource count
Part 2: tBRCA84
Part 2: Non-tBRCA LOH+73
Part 2: Non-tBRCA LOH-107
Part 2: Non-tBRCA LOH Unknown23

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 2: tBRCA22.7Not reported16.728.6Not reported
Part 2: Non-tBRCA LOH+14.7Not reported10.819.8Not reported
Part 2: Non-tBRCA LOH-13.3Not reported9.116.0Not reported
Part 2: Non-tBRCA LOH Unknown14.1Not reported7.420.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.7
        upper Limit
        28.6
        value
        22.7
      2. group Id
        OG001
        lower Limit
        10.8
        upper Limit
        19.8
        value
        14.7
      3. group Id
        OG002
        lower Limit
        9.1
        upper Limit
        16.0
        value
        13.3
      4. group Id
        OG003
        lower Limit
        7.4
        upper Limit
        20.1
        value
        14.1
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    2. group Id
      OG001
      value
      73
    3. group Id
      OG002
      value
      107
    4. group Id
      OG003
      value
      23
    units
    Participants
description
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a deleterious BRCA mutation detected in their tumor.
    id
    OG000
    title
    Part 2: tBRCA
  2. description
    Patients without a BRCA mutation in their tumor, but have high LOH.
    id
    OG001
    title
    Part 2: Non-tBRCA LOH+
  3. description
    Patients without a BRCA mutation in their tumor, but have low LOH.
    id
    OG002
    title
    Part 2: Non-tBRCA LOH-
  4. description
    Patients without a BRCA mutation in their tumor, and have unknown LOH due to missing results and/or failed test result(s).
    id
    OG003
    title
    Part 2: Non-tBRCA LOH Unknown
param Type
MEDIAN
population Description
Safety population by HRD subgroups: Consist of all Part 2 patients who received at least one dose of rucaparib.
reporting Status
POSTED
time Frame
All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years.
title
Overall Survival (Part 2 of Study)
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice