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NCT00865969 · OUTCOME

Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma · Source last updated 2021-10-29

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
24 months

What was measured

A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities.

Analysis population: Full Analysis Dataset included all participants who received at least 1 dose of belinostat.

Groups in this outcome

Belinostat

Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.

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

Analysis denominator · Participants

GroupSource count
Belinostat129

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belinostat61Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        61
denoms
  1. counts
    1. group Id
      OG000
      value
      129
    units
    Participants
description
A TEAE was defined as an event with an onset date and time on or after the first dosing start date and time, or on or after the first dosing start date if the onset time was missing. A serious TEAE was any untoward medical occurrence that at any dose results in death, prolonged hospitalization, persistent or significant disability or congenital abnormalities.
groups
  1. description
    Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
    id
    OG000
    title
    Belinostat
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Dataset included all participants who received at least 1 dose of belinostat.
reporting Status
POSTED
time Frame
24 months
title
Number of Participants With At Least One Serious Treatment-Emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice