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NCT00281918 · OUTCOME

Final Analysis: Time to Overall Survival Event

Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia · Source last updated 2013-09-19

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

Measure
MEDIAN
Unit
Days
Interval / dispersion
95% Confidence Interval
Time frame
Median observation time was approximately 66.4 months

What was measured

Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.

Analysis population: Participants from the Intent-to-treat population, that included all randomized participants who died.

Groups in this outcome

Fludarabine+Cyclophosphamide (FC)

Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.

Fludarabine+Cyclophosphamide+Rituximab (FCR)

Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 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
Fludarabine+Cyclophosphamide (FC)154
Fludarabine+Cyclophosphamide+Rituximab (FCR)125

Reported measurements

Source class 1
Values in Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)2613.0Not reported2354NAUpper limit of the 95% confidence interval has not been reached.
Fludarabine+Cyclophosphamide+Rituximab (FCR)NANot reported2745NAMedian time to event and upper limit of the 95% confidence have not been reached.

Source statistical analyses

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

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.86
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    param Type
    Hazard Ratio (HR)
    param Value
    0.68
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of the 95% confidence interval has not been reached.
        group Id
        OG000
        lower Limit
        2354
        upper Limit
        NA
        value
        2613.0
      2. comment
        Median time to event and upper limit of the 95% confidence have not been reached.
        group Id
        OG001
        lower Limit
        2745
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      154
    2. group Id
      OG001
      value
      125
    units
    Participants
description
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
    id
    OG000
    title
    Fludarabine+Cyclophosphamide (FC)
  2. description
    Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
    id
    OG001
    title
    Fludarabine+Cyclophosphamide+Rituximab (FCR)
param Type
MEDIAN
population Description
Participants from the Intent-to-treat population, that included all randomized participants who died.
reporting Status
POSTED
time Frame
Median observation time was approximately 66.4 months
title
Final Analysis: Time to Overall Survival Event
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice