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NCT01282424 · OUTCOME

Overall Response Rate

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas · Source last updated 2019-07-11

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
Start of Treatment to End of Treatment (up to 81 months)

What was measured

Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)

Analysis population: ITT Analysis Set included enrolled participants who received at least one dose of study drug.

Groups in this outcome

Idelalisib

Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Idelalisib125

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Idelalisib57.6Not reported48.466.4Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    The null hypothesis is ≤ 20%.
    statistical Method
    Exact binomial test
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    The null hypothesis is ≤ 20%.
    statistical Method
    Exact binomial test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.4
        upper Limit
        66.4
        value
        57.6
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    units
    Participants
description
Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the percentage of participants achieving a complete response (CR) or partial response (PR; or minor response \[MR\] for participants with WM) as assessed by the study independent review committee (IRC). CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions. For WM only, response was defined as a reduction in immunoglobulin M (IgM) of ≥ 50% decrease for PR, and ≥ 25% decrease for MR; no increase from baseline in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions or signs and symptoms of active disease (Owen, 2013)
dispersion Type
95% Confidence Interval
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
    id
    OG000
    title
    Idelalisib
param Type
NUMBER
population Description
ITT Analysis Set included enrolled participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Start of Treatment to End of Treatment (up to 81 months)
title
Overall Response Rate
type
PRIMARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice