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NCT01968213 · OUTCOME

Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)

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
Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.

What was measured

Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

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 Tablets10.8Not reported8.311.4Not reported
Placebo Tablets5.4Not reported5.35.5Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.295
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.451
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.
    p Value
    <0.0001
    param Type
    Cox Proportional Hazard
    param Value
    0.365
    statistical Method
    Regression, Cox
Complete source fields
analyses
  1. ci Lower Limit
    0.295
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.451
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    Analysis is performed by randomization strata of HRD classification by CTA, best response, and penultimate platinum progression-free interval.
    p Value
    <0.0001
    param Type
    Cox Proportional Hazard
    param Value
    0.365
    statistical Method
    Regression, Cox
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.3
        upper Limit
        11.4
        value
        10.8
      2. group Id
        OG001
        lower Limit
        5.3
        upper Limit
        5.5
        value
        5.4
denoms
  1. counts
    1. group Id
      OG000
      value
      375
    2. group Id
      OG001
      value
      189
    units
    Participants
description
Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
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
Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.
title
Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice