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NCT00281918 · OUTCOME

Overall Survival (OS)

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
NUMBER
Unit
Days
Interval / dispersion
Not reported
Time frame
Median observation time at time of analysis was approximately 21 months

What was measured

Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.

Analysis population: The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.

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)407
Fludarabine+Cyclophosphamide+Rituximab (FCR)403

Reported measurements

Minimum number of days to an event
Values in Days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)5Not reported8390Not reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)4Not reported8995Not reported
Maximum number of days to an event
Values in Days · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine+Cyclophosphamide (FC)1373Not reportedNot reportedNot reportedNot reported
Fludarabine+Cyclophosphamide+Rituximab (FCR)1372Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0427
    statistical Method
    Log Rank
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Pct Value
    95
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0427
    statistical Method
    Log Rank
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        83
        upper Limit
        90
        value
        5
      2. group Id
        OG001
        lower Limit
        89
        upper Limit
        95
        value
        4
    title
    Minimum number of days to an event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1373
      2. group Id
        OG001
        value
        1372
    title
    Maximum number of days to an event
denoms
  1. counts
    1. group Id
      OG000
      value
      407
    2. group Id
      OG001
      value
      403
    units
    Participants
description
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
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
NUMBER
population Description
The ITT population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not. Informed consent was unavailable at the time of analysis for 2 patients in the FC group and 5 patients in the FCR group. ITT population: FC = 407; FCR = 403.
reporting Status
POSTED
time Frame
Median observation time at time of analysis was approximately 21 months
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Days

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Preserved source evidence · Not medical advice