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NCT01105247 · OUTCOME

Progression Free Survival Rate at 24 Months

Safety of PCI-32765 in Chronic Lymphocytic Leukemia · Source last updated 2014-03-31

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
95% Confidence Interval
Time frame
The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).

What was measured

Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.

Groups in this outcome

Treatment Naive

PCI-32765: 420 mg daily or 840 mg daily

Relapsed/ Refractory

PCI-32765: 420 mg daily or 840 mg daily

Food- Effect

Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily

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 Naive31
Relapsed/ Refractory85
Food- Effect16

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment Naive96.3Not reported76.599.5Not reported
Relapsed/ Refractory73.6Not reported60.283.1Not reported
Food- EffectNANot reportedNANAThere was no PD or death occurred in this arm.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        76.5
        upper Limit
        99.5
        value
        96.3
      2. group Id
        OG001
        lower Limit
        60.2
        upper Limit
        83.1
        value
        73.6
      3. comment
        There was no PD or death occurred in this arm.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      85
    3. group Id
      OG002
      value
      16
    units
    Participants
description
Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.
dispersion Type
95% Confidence Interval
groups
  1. description
    PCI-32765: 420 mg daily or 840 mg daily
    id
    OG000
    title
    Treatment Naive
  2. description
    PCI-32765: 420 mg daily or 840 mg daily
    id
    OG001
    title
    Relapsed/ Refractory
  3. description
    Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
    id
    OG002
    title
    Food- Effect
param Type
NUMBER
reporting Status
POSTED
time Frame
The median follow-up time for all treated patients are 21 month, range (0.7 month, 29 months).
title
Progression Free Survival Rate at 24 Months
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice