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NCT03364231 · OUTCOME

Number of Participants With at Least One Adverse Event (AE)

Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma · Source last updated 2023-06-23

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
From first dose of study treatment up to end of study (up to approximately 4.2 years)

What was measured

An AE is any untoward medical occurrence in a participant that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Analysis population: Safety population included all enrolled participants who received at least one dose of study treatment.

Groups in this outcome

MZL: Umbralisib

Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity or withdrawal from the study whichever occurred first.

WM: Umbralisib

Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
MZL: Umbralisib8
WM: Umbralisib13

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
MZL: Umbralisib8Not reportedNot reportedNot reportedNot reported
WM: Umbralisib13Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      13
    units
    Participants
description
An AE is any untoward medical occurrence in a participant that does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
groups
  1. description
    Participants with non-follicular iNHL with MZL as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity or withdrawal from the study whichever occurred first.
    id
    OG000
    title
    MZL: Umbralisib
  2. description
    Participants with non-follicular iNHL with WM as the histology type received umbralisib, 800 mg, orally, QD, until disease progression, unacceptable toxicity, or withdrawal from the study whichever occurred first.
    id
    OG001
    title
    WM: Umbralisib
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety population included all enrolled participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
From first dose of study treatment up to end of study (up to approximately 4.2 years)
title
Number of Participants With at Least One Adverse Event (AE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice