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NCT01105247 · OUTCOME

Percentage of Participants Achieving Response

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

Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction 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 Naive71Not reported5285.8Not reported
Relapsed/ Refractory75.3Not reported64.784Not reported
Food Effect56.3Not reported29.980.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        52
        upper Limit
        85.8
        value
        71
      2. group Id
        OG001
        lower Limit
        64.7
        upper Limit
        84
        value
        75.3
      3. group Id
        OG002
        lower Limit
        29.9
        upper Limit
        80.2
        value
        56.3
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      85
    3. group Id
      OG002
      value
      16
    units
    Participants
description
Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction 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
Percentage of Participants Achieving Response
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice