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NCT02548962 · OUTCOME

Duration of Response (DOR)

Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
Full Range
Time frame
14 Months

What was measured

The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.

Analysis population: Median was not reached for Phase 1: Dose Finding (560 mg). Median value provided here was the median and range (min and max).

Groups in this outcome

Phase 1: Dose Finding (560 mg)

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (560mg) Pomalidomide (4mg) Dexamethasone (40mg)

Phase 1: Dose Finding (840 mg)

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (840mg) Pomalidomide (4mg) Dexamethasone (40mg)

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

Analysis denominator · Participants

GroupSource count
Phase 1: Dose Finding (560 mg)3
Phase 1: Dose Finding (840 mg)1

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 1: Dose Finding (560 mg)6.5Not reported5.111.8Not reported
Phase 1: Dose Finding (840 mg)7.3Not reported7.37.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.1
        upper Limit
        11.8
        value
        6.5
      2. group Id
        OG001
        lower Limit
        7.3
        upper Limit
        7.3
        value
        7.3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      1
    units
    Participants
description
The time interval between the date of initial documentation of a response and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects not progressed/died. The censoring date is the last adequate tumor assessment date.
dispersion Type
Full Range
groups
  1. description
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (560mg) Pomalidomide (4mg) Dexamethasone (40mg)
    id
    OG000
    title
    Phase 1: Dose Finding (560 mg)
  2. description
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (840mg) Pomalidomide (4mg) Dexamethasone (40mg)
    id
    OG001
    title
    Phase 1: Dose Finding (840 mg)
param Type
MEDIAN
population Description
Median was not reached for Phase 1: Dose Finding (560 mg). Median value provided here was the median and range (min and max).
reporting Status
POSTED
time Frame
14 Months
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice