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NCT00511238 · OUTCOME

Duration of Response (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
days
Interval / dispersion
95% Confidence Interval
Time frame
Response assessments same as described in primary outcome measure

What was measured

Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or death.

Analysis population: Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.

Groups in this outcome

Carfilzomib (A0) for (ORR)

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) for (ORR)7

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib (A0) for (ORR)219Not reported57NAThe upper limit of the 95% confidence interval was not calculable/available (not estimable \[NE\]) because an insufficient number of participants reached the event at the final time point for assessment (3 of 7 responders had an event).
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% confidence interval was not calculable/available (not estimable \[NE\]) because an insufficient number of participants reached the event at the final time point for assessment (3 of 7 responders had an event).
        group Id
        OG000
        lower Limit
        57
        upper Limit
        NA
        value
        219
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Duration of response (DOR) was calculated separately for subjects with clinical benefit response or overall response. DOR is defined as the time from first evidence of PR or better (for overall response) and MR or better (for clinical benefit response) to start of disease progression or 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) for (ORR)
param Type
MEDIAN
population Description
Subjects with overall response within the response-evaluable population were included in the analysis of DOR. See analysis population description of response-evaluable population above.
reporting Status
POSTED
time Frame
Response assessments same as described in primary outcome measure
title
Duration of Response (A0 Only)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice