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NCT02004522 · OUTCOME

Treatment-Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO) · Source last updated 2023-09-21

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 04 Feb 2014 till 19 June 2018

What was measured

An analysis of TEAEs with an onset within the first 24 weeks of treatment was performed to examine and compare the incidence of events across an equal period for each treatment arm.Twenty-four weeks was anticipated to be the median exposure to ofatumumab.

Analysis population: Intent to Treat

Groups in this outcome

Duvelisib

Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.

Ofatumumab

Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.

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

Analysis denominator · Participants

GroupSource count
Duvelisib160
Ofatumumab159

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Duvelisib150Not reportedNot reportedNot reportedNot reported
Ofatumumab143Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        150
      2. group Id
        OG001
        value
        143
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      159
    units
    Participants
description
An analysis of TEAEs with an onset within the first 24 weeks of treatment was performed to examine and compare the incidence of events across an equal period for each treatment arm.Twenty-four weeks was anticipated to be the median exposure to ofatumumab.
groups
  1. description
    Duvelisib is administered orally and supplied as 5 mg and 25 mg formulated capsules.
    id
    OG000
    title
    Duvelisib
  2. description
    Ofatumumab is administered as an IV infusion and is supplied in single-use vials at two strengths, 100 mg/5 mL and 1000 mg/50 mL.
    id
    OG001
    title
    Ofatumumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Intent to Treat
reporting Status
POSTED
time Frame
From 04 Feb 2014 till 19 June 2018
title
Treatment-Emergent Adverse Events (TEAEs) and Changes in Safety Laboratory Values
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice