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NCT02855944 · OUTCOME

Overall Survival (Efficacy Population)

ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients · Source last updated 2023-06-09

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 were followed for survival up to approximately 3.5 years.

What was measured

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.

Analysis population: Efficacy Population - All randomized patients in the treatment part of study with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.

Groups in this outcome

Rucaparib

Patients randomized to the rucaparib arm.

Chemotherapy

Patients randomized to the chemotherapy arm.

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

Analysis denominator · Participants

GroupSource count
Rucaparib220
Chemotherapy105

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rucaparib21.1Not reported17.924.9Not reported
Chemotherapy26.2Not reported22.229.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.9
        upper Limit
        24.9
        value
        21.1
      2. group Id
        OG001
        lower Limit
        22.2
        upper Limit
        29.1
        value
        26.2
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    2. group Id
      OG001
      value
      105
    units
    Participants
description
Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients randomized to the rucaparib arm.
    id
    OG000
    title
    Rucaparib
  2. description
    Patients randomized to the chemotherapy arm.
    id
    OG001
    title
    Chemotherapy
param Type
MEDIAN
population Description
Efficacy Population - All randomized patients in the treatment part of study with a deleterious BRCA mutation, excluding those identified to have a BRCA reversion mutation. As noted in the Baseline Characteristics Module, 1 patient in the Chemotherapy Arm did not have a BRCA mutation (Non-BRCA) and is therefore excluded from the overall number of patients analyzed.
reporting Status
POSTED
time Frame
All patients were followed for survival up to approximately 3.5 years.
title
Overall Survival (Efficacy Population)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice