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NCT01282424 · OUTCOME

Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Start of Treatment to End of Treatment (up to 81 months) plus 30 days

What was measured

This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.

Analysis population: Participants in the ITT Analysis Set were analyzed.

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

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib123Not reportedNot reportedNot reportedNot reported
AE leading to drug discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib35Not reportedNot reportedNot reportedNot reported
Serious AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib72Not reportedNot reportedNot reportedNot reported
Vital signs abnormal - clinically meaningful
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib0Not reportedNot reportedNot reportedNot reported
ECG abnormal - clinically meaningful
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib0Not reportedNot reportedNot reportedNot reported
Grade 3 or 4 hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib2Not reportedNot reportedNot reportedNot reported
Grade 3 or 4 neutrophils
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib35Not reportedNot reportedNot reportedNot reported
Grade 3 or 4 platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib9Not reportedNot reportedNot reportedNot reported
Grade 3 or 4 alanine aminotransferase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib16Not reportedNot reportedNot reportedNot reported
Grade 3 or 4 aspartate aminotransferase
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Idelalisib11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        123
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    AE leading to drug discontinuation
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        72
    title
    Serious AE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Vital signs abnormal - clinically meaningful
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ECG abnormal - clinically meaningful
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Grade 3 or 4 hemoglobin
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    Grade 3 or 4 neutrophils
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Grade 3 or 4 platelets
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Grade 3 or 4 alanine aminotransferase
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Grade 3 or 4 aspartate aminotransferase
denoms
  1. counts
    1. group Id
      OG000
      value
      125
    units
    Participants
description
This composite endpoint measured the safety and tolerability profile of idelalisib. "Clinically meaningful" abnormalities in vital signs and electrocardiograms (ECG) were as determined by the investigator.
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
COUNT_OF_PARTICIPANTS
population Description
Participants in the ITT Analysis Set were analyzed.
reporting Status
POSTED
time Frame
Start of Treatment to End of Treatment (up to 81 months) plus 30 days
title
Safety and Tolerability of Idelalisib Assessed as the Number of Participants Experiencing Adverse Events (AEs) or Abnormalities in Vital Signs, Laboratory Tests, or Electrocardiograms
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice