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NCT02048371 · OUTCOME

Progression-free Survival (PFS), Cohorts A and B, After Crossover.

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes · Source last updated 2023-11-07

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
up to 3 years

What was measured

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.

Analysis population: Participants who started on placebo in Cohorts A and B, then crossed over to active drug after progression.

Groups in this outcome

Cohort A: Liposarcoma Crossover

Participants who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

Cohort B: Osteosarcoma Crossover

Participants who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off

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

Analysis denominator · Participants

GroupSource count
Cohort A: Liposarcoma Crossover15
Cohort B: Osteosarcoma Crossover11

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A: Liposarcoma Crossover1.68Not reported0.925.59Not reported
Cohort B: Osteosarcoma Crossover5.78Not reported3.55NAThe upper limit of the CI is below the level of detection.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.92
        upper Limit
        5.59
        value
        1.68
      2. comment
        The upper limit of the CI is below the level of detection.
        group Id
        OG001
        lower Limit
        3.55
        upper Limit
        NA
        value
        5.78
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      11
    units
    Participants
description
The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG000
    title
    Cohort A: Liposarcoma Crossover
  2. description
    Participants who started on placebo and crossed over to active drug. Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off Regorafenib Regorafenib: Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
    id
    OG001
    title
    Cohort B: Osteosarcoma Crossover
param Type
MEDIAN
population Description
Participants who started on placebo in Cohorts A and B, then crossed over to active drug after progression.
reporting Status
POSTED
time Frame
up to 3 years
title
Progression-free Survival (PFS), Cohorts A and B, After Crossover.
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice