Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01968213 · OUTCOME

Time to an 8-point Decrease in the Total Score of the FOSI-18

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) · 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
Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.

What was measured

The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.

Analysis population: Intent-to-treat: All patients randomized

Groups in this outcome

Rucaparib 600 mg Tablets

Taken orally twice daily (continuous 28 day treatment cycles)

Placebo Tablets

Taken orally twice daily (continuous 28 day treatment cycles)

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

Analysis denominator · Participants

GroupSource count
Rucaparib 600 mg Tablets375
Placebo Tablets189

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rucaparib 600 mg Tablets2.9Not reported2.73.7Not reported
Placebo Tablets10.8Not reported9.217.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.7
        upper Limit
        3.7
        value
        2.9
      2. group Id
        OG001
        lower Limit
        9.2
        upper Limit
        17.5
        value
        10.8
denoms
  1. counts
    1. group Id
      OG000
      value
      375
    2. group Id
      OG001
      value
      189
    units
    Participants
description
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    OG000
    title
    Rucaparib 600 mg Tablets
  2. description
    Taken orally twice daily (continuous 28 day treatment cycles)
    id
    OG001
    title
    Placebo Tablets
param Type
MEDIAN
population Description
Intent-to-treat: All patients randomized
reporting Status
POSTED
time Frame
Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
title
Time to an 8-point Decrease in the Total Score of the FOSI-18
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice