Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01965834 · OUTCOME

Proportion of Participants Achieving Progression-Free Survival

Phase II Study to Evaluate Fenofibrate Therapy in Patients With Smoldering or Symptomatic Multiple Myeloma · Source last updated 2017-06-14

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
6 months, 12 months

What was measured

Proportion of participants achieving progression-free survival. Measured from date of initiation of treatment (Day 1) to the earliest occurrence of any of the following events: documented disease progression, or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status.

Groups in this outcome

Fenofibrate Therapy

Fenofibrate orally daily for each 28 day cycle, per study protocol. Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.

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

Analysis denominator · Participants

GroupSource count
Fenofibrate Therapy6

Reported measurements

6 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy0Not reportedNot reportedNot reportedNot reported
12 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    6 months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Proportion of participants achieving progression-free survival. Measured from date of initiation of treatment (Day 1) to the earliest occurrence of any of the following events: documented disease progression, or death from any cause. Patients who are alive and progression-free will be censored at the date of last documented progression-free status.
groups
  1. description
    Fenofibrate orally daily for each 28 day cycle, per study protocol. Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance \< 50 mL/min will receive a reduced dose of 54 mg orally daily.
    id
    OG000
    title
    Fenofibrate Therapy
param Type
NUMBER
reporting Status
POSTED
time Frame
6 months, 12 months
title
Proportion of Participants Achieving Progression-Free Survival
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice