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NCT00131937 · OUTCOME

Progression-Free Survival (PFS)

Sorafenib Tosylate in Treating Patients With Recurrent Aggressive Non-Hodgkin's Lymphoma · Source last updated 2015-09-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
90% Confidence Interval
Time frame
Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years

What was measured

PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as: 1. Appearances of any new lesions/sites during or after therapy 2. Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site 3. Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node \>1.0 cm in its short axis

Groups in this outcome

Treatment (Sorafenib)

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally

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

Analysis denominator · Participants

GroupSource count
Treatment (Sorafenib)14

Reported measurements

Source class 1
Values in months · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Sorafenib)2Not reported15Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        5
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
PFS is defined as the time from randomization to the first of progression, relapse or death from any cause. Per criteria from International Workshop to Standardize Criteria for NHL (Cheson, 1999), progression (for patients who have not responded) and relapse (for patients who responded) are defined as: 1. Appearances of any new lesions/sites during or after therapy 2. Increase of ≥50% in the SPD from nadir measurement of all involved dominant lymph nodes and liver/spleen nodules or unequivocal progression in any nonmeasurable disease or nondominant site 3. Increase by ≥50% in greatest diameter from nadir measurement of any previously involved dominant node \>1.0 cm in its short axis
dispersion Type
90% Confidence Interval
groups
  1. description
    Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sorafenib tosylate: Given orally
    id
    OG000
    title
    Treatment (Sorafenib)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Assessed after month 2 and month 6, then every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-3 years from study entry, up to 3 years
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice