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NCT02545907 · OUTCOME

Time to Maximum Response Based on Reported Data.

A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis · Source last updated 2021-04-15

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
Within 6 months

What was measured

The time to maximum response to treatment will be assessed by determining the time required for each participant to achieve maximum response (defined above), and will be presented on Kaplan-Meier curves. The number of months taken to achieve this maximum response will be reported. Time to maximum response was analysed overall only, and not by arm due the small sample size.

Groups in this outcome

Safety Population

All patients that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set..

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

Analysis denominator · Participants

GroupSource count
Safety Population10

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety Population5.3Not reportedNANASeven out of 10 participants achieved a maximum response. Two participants who experienced DLTs were not evaluable for response and one participant who discontinued after two cycles of treatment did not achieve a response. Corresponding 95% confidence intervals is not calculable due to the low number of events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Seven out of 10 participants achieved a maximum response. Two participants who experienced DLTs were not evaluable for response and one participant who discontinued after two cycles of treatment did not achieve a response. Corresponding 95% confidence intervals is not calculable due to the low number of events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        5.3
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
The time to maximum response to treatment will be assessed by determining the time required for each participant to achieve maximum response (defined above), and will be presented on Kaplan-Meier curves. The number of months taken to achieve this maximum response will be reported. Time to maximum response was analysed overall only, and not by arm due the small sample size.
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set..
    id
    OG000
    title
    Safety Population
param Type
MEDIAN
reporting Status
POSTED
time Frame
Within 6 months
title
Time to Maximum Response Based on Reported Data.
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice