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NCT00429949 · OUTCOME

Event-free Survival (EFS) for Participants With Plateau Phase Disease

A Phase II Study of Dasatinib in the Treatment of Relapsed or Plateau Phase Multiple Myeloma · Source last updated 2014-08-29

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
Completion of treatment (median duration of therapy was 51 days)

What was measured

EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.

Groups in this outcome

Dasatinib

Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 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
Dasatinib7

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dasatinib138Not reported73.8202.2Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73.8
        upper Limit
        202.2
        value
        138
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
EFS is defined as time from the start of the treatment until the first date that criteria for progressive disease are met, therapy was discontinued for toxicity, or death, whichever occurs first. Those patients alive will be censored at the date of last clinical contact. If progression is based upon serum or urine paraprotein measurements, which must be repeated for confirmation, event-free progression is still measured from the start of treatment until the first date that progression is detected.
dispersion Type
95% Confidence Interval
groups
  1. description
    Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle. In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
    id
    OG000
    title
    Dasatinib
param Type
MEDIAN
reporting Status
POSTED
time Frame
Completion of treatment (median duration of therapy was 51 days)
title
Event-free Survival (EFS) for Participants With Plateau Phase Disease
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice