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NCT01374217 · OUTCOME

Time to Progression

Administration of Tadalafil in Conjunction With Lenalidomide and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2018-12-10

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Up to 71 days

What was measured

Median time to progression of disease in days.

Analysis population: One participant was not analyzed because he only received eight days of study drug prior to progression and removal from study. One participant was retrospectively ineligible and was therefore not analyzed.

Groups in this outcome

Tadalafil

Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd) Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days Lenalidomide: Lenalidomide will be administered as it was prior to study entry. Dexamethasone: Dexamethasone will be administered as it was prior to study entry. Clarithromycin: Clarithromycin will be administered as it was prior to study entry.

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

Analysis denominator · Participants

GroupSource count
Tadalafil11

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Tadalafil48Not reported2571Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        25
        upper Limit
        71
        value
        48
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Median time to progression of disease in days.
dispersion Type
95% Confidence Interval
groups
  1. description
    Subject will take tadalafil in combination with with Lenalidomide and dexamethasone (Rd) or Clarithromycin/Lenalidomide/ dexamethasone (BiRd) Tadalafil: Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days Lenalidomide: Lenalidomide will be administered as it was prior to study entry. Dexamethasone: Dexamethasone will be administered as it was prior to study entry. Clarithromycin: Clarithromycin will be administered as it was prior to study entry.
    id
    OG000
    title
    Tadalafil
param Type
MEDIAN
population Description
One participant was not analyzed because he only received eight days of study drug prior to progression and removal from study. One participant was retrospectively ineligible and was therefore not analyzed.
reporting Status
POSTED
time Frame
Up to 71 days
title
Time to Progression
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice