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NCT01891344 · OUTCOME

Objective Response Rate (ORR) by RECIST v1.1 (Part 1 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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.

What was measured

The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

Analysis population: Safety population by HRD subgroups: Consist of all Part 1 patients who received at least one dose of rucaparib

Groups in this outcome

Part 1: tBRCA

Patients with a deleterious BRCA mutation detected in their tumor.

Part 1: Non-tBRCA LOH+

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

Part 1: Non-tBRCA LOH-

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

Part 1: 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 1: tBRCA40
Part 1: Non-tBRCA LOH+82
Part 1: Non-tBRCA LOH-70
Part 1: Non-tBRCA LOH Unknown12

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part 1: tBRCA80.0Not reported64.490.9Not reported
Part 1: Non-tBRCA LOH+28.0Not reported18.739.1Not reported
Part 1: Non-tBRCA LOH-10.0Not reported4.119.5Not reported
Part 1: Non-tBRCA LOH Unknown33.3Not reported9.965.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.4
        upper Limit
        90.9
        value
        80.0
      2. group Id
        OG001
        lower Limit
        18.7
        upper Limit
        39.1
        value
        28.0
      3. group Id
        OG002
        lower Limit
        4.1
        upper Limit
        19.5
        value
        10.0
      4. group Id
        OG003
        lower Limit
        9.9
        upper Limit
        65.1
        value
        33.3
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    2. group Id
      OG001
      value
      82
    3. group Id
      OG002
      value
      70
    4. group Id
      OG003
      value
      12
    units
    Participants
description
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a deleterious BRCA mutation detected in their tumor.
    id
    OG000
    title
    Part 1: tBRCA
  2. description
    Patients without a BRCA mutation in their tumor, but have high LOH.
    id
    OG001
    title
    Part 1: Non-tBRCA LOH+
  3. description
    Patients without a BRCA mutation in their tumor, but have low LOH.
    id
    OG002
    title
    Part 1: 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 1: Non-tBRCA LOH Unknown
param Type
NUMBER
population Description
Safety population by HRD subgroups: Consist of all Part 1 patients who received at least one dose of rucaparib
reporting Status
POSTED
time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
title
Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice