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NCT00790400 · OUTCOME

Percentage of Participants With Renal Impairment

Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) · Source last updated 2017-02-17

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

Measure
NUMBER
Unit
Percentage of Participants
Interval / dispersion
Not reported
Time frame
Day 1 up to 28 days after end of treatment

What was measured

Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of \<30ml/min/1.73m2.

Analysis population: Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.

Groups in this outcome

Everolimus Randomized (Core Period)

Study drug was given by continuous oral daily dosing of two 5 mg tablets.

Placebo Randomized (Core Period)

Placebo was given by continuous oral daily dosing of two 5 mg tablets.

Everolimus (Core and/or Extension Period)

Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.

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

Analysis denominator · Participants

GroupSource count
Everolimus Randomized (Core Period)79
Placebo Randomized (Core Period)39
Everolimus (Core and/or Extension Period)112

Reported measurements

Glomerular filtration rate <30 ml/min/1.73m^2
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)2.5Not reportedNot reportedNot reportedNot reported
Placebo Randomized (Core Period)7.7Not reportedNot reportedNot reportedNot reported
Everolimus (Core and/or Extension Period)7.1Not reportedNot reportedNot reportedNot reported
Glomerular filtration rate≥ 30 ml/min/1.73m^2
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus Randomized (Core Period)97.5Not reportedNot reportedNot reportedNot reported
Placebo Randomized (Core Period)92.3Not reportedNot reportedNot reportedNot reported
Everolimus (Core and/or Extension Period)92.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2.5
      2. group Id
        OG001
        value
        7.7
      3. group Id
        OG002
        value
        7.1
    title
    Glomerular filtration rate <30 ml/min/1.73m^2
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        97.5
      2. group Id
        OG001
        value
        92.3
      3. group Id
        OG002
        value
        92.9
    title
    Glomerular filtration rate≥ 30 ml/min/1.73m^2
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      39
    3. group Id
      OG002
      value
      112
    units
    Participants
description
Renal Impairment was measured by glomerular filtration rate which was calculated using the Modification of Diet in Renal Disease formula. Percentage of participants with renal impairment was reported. Severe renal impairment was defined as a GFR of \<30ml/min/1.73m2.
groups
  1. description
    Study drug was given by continuous oral daily dosing of two 5 mg tablets.
    id
    OG000
    title
    Everolimus Randomized (Core Period)
  2. description
    Placebo was given by continuous oral daily dosing of two 5 mg tablets.
    id
    OG001
    title
    Placebo Randomized (Core Period)
  3. description
    Patients initially randomized in everolimus and patients initially randomized in placebo but who crossed-over to everolimus during extension.
    id
    OG002
    title
    Everolimus (Core and/or Extension Period)
param Type
NUMBER
population Description
Safety set consists of all patients who received at least 1 dose of the double-blind study drug with a valid post-baseline assessment. For the everolimus (core/extension) treatment arm, patients received at least 1 dose of everolimus with a valid post-baseline assessment, where baseline was defined as the assessment just before start of everolimus.
reporting Status
POSTED
time Frame
Day 1 up to 28 days after end of treatment
title
Percentage of Participants With Renal Impairment
type
SECONDARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice