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NCT00511238 · OUTCOME

Progression-free Survival (A0 Only)

Phase 2 Study of Carfilzomib in Relapsed and Refractory Multiple Myeloma · Source last updated 2017-08-31

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
Response assessments same as described in primary outcome measure

What was measured

The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.

Analysis population: Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.

Groups in this outcome

Carfilzomib (A0)

Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle

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

Analysis denominator · Participants

GroupSource count
Carfilzomib (A0)42

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib (A0)3.5Not reported2.46.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.4
        upper Limit
        6.7
        value
        3.5
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    units
    Participants
description
The PFS was defined as the time from the start of treatment to progressive disease (PD) determined by PI or until death.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
    id
    OG000
    title
    Carfilzomib (A0)
param Type
MEDIAN
population Description
Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib.
reporting Status
POSTED
time Frame
Response assessments same as described in primary outcome measure
title
Progression-free Survival (A0 Only)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice