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NCT01965834 · OUTCOME

Number of Subjects Experiencing Adverse Events

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
Up to 8 months

What was measured

To evaluate safety and tolerability of fenofibrate therapy in patients with multiple myeloma.

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

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fenofibrate Therapy5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
To evaluate safety and tolerability of fenofibrate therapy in patients with multiple myeloma.
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
Up to 8 months
title
Number of Subjects Experiencing Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice