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NCT02004522 · OUTCOME

Overall Survival

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
Every 6 months for up to 3 years after first dose

What was measured

A stratified Cox regression analysis was used to test for any treatment effect.

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
Duvelisib54.94Not reported43.0067.99Not reported
Ofatumumab63.25Not reported44.15NANA = The upper limit of the confidence interval is not estimable because of an insufficient number of events at the time of analysis.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        43.00
        upper Limit
        67.99
        value
        54.94
      2. comment
        NA = The upper limit of the confidence interval is not estimable because of an insufficient number of events at the time of analysis.
        group Id
        OG001
        lower Limit
        44.15
        upper Limit
        NA
        value
        63.25
denoms
  1. counts
    1. group Id
      OG000
      value
      160
    2. group Id
      OG001
      value
      159
    units
    Participants
description
A stratified Cox regression analysis was used to test for any treatment effect.
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
Every 6 months for up to 3 years after first dose
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice