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NCT01057225 · OUTCOME

Time to Treatment Failure

Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma · Source last updated 2017-12-12

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

Measure
NUMBER
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From baseline to end of active treatment

What was measured

The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier

Analysis population: All enrolled patients who began treatment were evaluated for safety and response.

Groups in this outcome

Arm I

Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.

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

Analysis denominator · Participants

GroupSource count
Arm I64

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm INANot reportedNANAThe median and 95% confidence interval for the time to treatment failure could not be estimated due to too few treatment failures.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The median and 95% confidence interval for the time to treatment failure could not be estimated due to too few treatment failures.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      64
    units
    Participants
description
The time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
    id
    OG000
    title
    Arm I
param Type
NUMBER
population Description
All enrolled patients who began treatment were evaluated for safety and response.
reporting Status
POSTED
time Frame
From baseline to end of active treatment
title
Time to Treatment Failure
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice