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NCT02086552 · OUTCOME

Progression-free Survival

Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2021-12-03

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
95% Confidence Interval
Time frame
Time from SCT to progression or death due to any cause, assessed at 2 years

What was measured

The progression-free survival time is defined as the time from SCT to progression or death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Here, we are reporting the proportion of patients that have not had a PFS event two years after SCT.

Analysis population: All patients that began protocol treatment and were evaluable were included in this endpoint.

Groups in this outcome

Treatment (Sonidegib, Lenalidomide)

Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Treatment (Sonidegib, Lenalidomide)26

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Sonidegib, Lenalidomide)0.76Not reported0.610.94Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.61
        upper Limit
        0.94
        value
        0.76
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The progression-free survival time is defined as the time from SCT to progression or death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. Here, we are reporting the proportion of patients that have not had a PFS event two years after SCT.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 400 mg sonidegib PO QD on days 1-28 and 10 mg lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Sonidegib, Lenalidomide)
param Type
NUMBER
population Description
All patients that began protocol treatment and were evaluable were included in this endpoint.
reporting Status
POSTED
time Frame
Time from SCT to progression or death due to any cause, assessed at 2 years
title
Progression-free Survival
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice