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NCT00789828 · OUTCOME

Percentage of Participants With Renal Impairment During Core Period

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) · Source last updated 2016-02-03

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 (Core period)

What was measured

Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788\*(serum creatinine (micromol/L)\^-1.154)\*(age\^-0.203 )\*(0.742, if female)\*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41\*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR \< 30 mL/min/1.73 m\^2 and participants with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.

Analysis population: The analysis was performed in the SAF population. Here, "Number of participants analysed" signifies the participants assessed for renal function during the study for each arm, respectively.

Groups in this outcome

Everolimus (Core Period)

Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.

Placebo (Core Period)

Participants received oral dose of placebo matching to everolimus 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
Everolimus (Core Period)78
Placebo (Core Period)39

Reported measurements

Grade 3 or 4
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)0Not reportedNot reportedNot reportedNot reported
Placebo (Core Period)0Not reportedNot reportedNot reportedNot reported
Grade 1 or 2
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)3.8Not reportedNot reportedNot reportedNot reported
Placebo (Core Period)0Not reportedNot reportedNot reportedNot reported
Grade 0
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Everolimus (Core Period)96.2Not reportedNot reportedNot reportedNot reported
Placebo (Core Period)100Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 3 or 4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3.8
      2. group Id
        OG001
        value
        0
    title
    Grade 1 or 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        96.2
      2. group Id
        OG001
        value
        100
    title
    Grade 0
denoms
  1. counts
    1. group Id
      OG000
      value
      78
    2. group Id
      OG001
      value
      39
    units
    Participants
description
Renal function was assessed using glomerular filtration rate (GFR) based on age measure; Modification of Diet in Renal Disease (MDRD) formula for participants aged 18 years or older, defined as GFR equal to 32788\*(serum creatinine (micromol/L)\^-1.154)\*(age\^-0.203 )\*(0.742, if female)\*(1.210, if black), and Schwartz formula for participants less than 18 years defined as GFR equal to 0.41\*height (cm)/ Serum creatinine (mg/dL). Participants with severe renal impairment defined as GFR \< 30 mL/min/1.73 m\^2 and participants with National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade 3/4 serum creatinine were reported.
groups
  1. description
    Participants received oral dose of everolimus 4.5 mg/m\^2 daily as an initial starting dose to attain the whole blood trough concentrations in range of 5-15 ng/mL. Dose adjustments were permitted based on safety and whole blood trough concentrations.
    id
    OG000
    title
    Everolimus (Core Period)
  2. description
    Participants received oral dose of placebo matching to everolimus daily.
    id
    OG001
    title
    Placebo (Core Period)
param Type
NUMBER
population Description
The analysis was performed in the SAF population. Here, "Number of participants analysed" signifies the participants assessed for renal function during the study for each arm, respectively.
reporting Status
POSTED
time Frame
Day 1 up to 28 days after end of treatment (Core period)
title
Percentage of Participants With Renal Impairment During Core Period
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice