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NCT02004522 · OUTCOME

Number of Subjects With Hematologic Improvements

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
3 years

What was measured

Subjects with hematologic improvement included those subjects with abnormally high values for neutrophil count, hemoglobin, or platelet count at Baseline determined to have consistently met the criteria of an improvement for those parameters for a period of at least 60 days during which the subject did not have a transfusion or exogenous cytokines.

Analysis population: Subjects With Abnormal Hematologic Values at Baseline

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
Duvelisib94
Ofatumumab95

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Duvelisib56Not reportedNot reportedNot reportedNot reported
Ofatumumab51Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        51
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    2. group Id
      OG001
      value
      95
    units
    Participants
description
Subjects with hematologic improvement included those subjects with abnormally high values for neutrophil count, hemoglobin, or platelet count at Baseline determined to have consistently met the criteria of an improvement for those parameters for a period of at least 60 days during which the subject did not have a transfusion or exogenous cytokines.
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
Subjects With Abnormal Hematologic Values at Baseline
reporting Status
POSTED
time Frame
3 years
title
Number of Subjects With Hematologic Improvements
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice