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NCT01722487 · OUTCOME

Overall Survival (OS)

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL · Source last updated 2017-11-30

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
Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.

What was measured

OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.

Analysis population: Intention to treat

Groups in this outcome

Ibrutinib

Ibrutinib 420 mg daily.

Chlorambucil

Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 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
Ibrutinib136
Chlorambucil133

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IbrutinibNANot reportedNANAIBR: Median OS was not reached so 95% CI for median OS is not applicable.
ChlorambucilNANot reportedNANACHL: Median OS was not reached so 95% CI for median OS is not applicable.

Source statistical analyses

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

  1. ci Lower Limit
    0.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.56
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    param Type
    Hazard Ratio (HR)
    param Value
    0.16
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.05
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.56
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0010
    param Type
    Hazard Ratio (HR)
    param Value
    0.16
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        IBR: Median OS was not reached so 95% CI for median OS is not applicable.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        CHL: Median OS was not reached so 95% CI for median OS is not applicable.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      136
    2. group Id
      OG001
      value
      133
    units
    Participants
description
OS is calculated for all randomized subjects as the duration of time from the date of randomization to the date of death due to any cause or the date last known alive for subjects who were not known to have died at study closure.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ibrutinib 420 mg daily.
    id
    OG000
    title
    Ibrutinib
  2. description
    Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
    id
    OG001
    title
    Chlorambucil
param Type
MEDIAN
population Description
Intention to treat
reporting Status
POSTED
time Frame
Analysis was conducted when 15 months had elapsed after the last subject was randomized with the cutoff date of 4 May 2015. The median follow-up time is 18 month.
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice