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NCT02004522 · OUTCOME

Progression-free Survival (PFS)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

What was measured

The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Duvelisib13.3Not reported12.116.8Not reported
Ofatumumab9.9Not reported9.211.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        12.1
        upper Limit
        16.8
        value
        13.3
      2. group Id
        OG001
        lower Limit
        9.2
        upper Limit
        11.3
        value
        9.9
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      159
    units
    Participants
description
The primary efficacy endpoint for the study was PFS, defined as time from randomization to the first documentation of PD as determined by blinded independent review or death due to any cause.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Intent to Treat
reporting Status
POSTED
time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
title
Progression-free Survival (PFS)
type
PRIMARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice