NCT00790400 · OUTCOME

Everolimus Trough Concentrations (Cmin)

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: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Prior to dosing at weeks 2, 4, 12, 24, 48

What was measured

Cmin values collected prior to dose administration on the same study day and at 20-28 hours after previous dose, at steady state, and patient did not vomit within 4 hours of previous dose. Samples collected during the first 4 days of dosing were excluded from all analyses.

Analysis population: The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.

Groups in this outcome

Everolimus Randomized (Core Period)

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

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

Analysis denominator · Participants

Group	Source count
Everolimus Randomized (Core Period)	79

Reported measurements

Prior to dosing at Week 2 (n:43)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	7.63	4.32	Not reported	Not reported	Not reported

Prior to dosing Week 4 (n:44)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	7.72	4.35	Not reported	Not reported	Not reported

Prior to dosing Week 12 (n:49)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	8.79	6.75	Not reported	Not reported	Not reported

Prior to dosing Week 24 (n:46)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	9.37	8.83	Not reported	Not reported	Not reported

Prior to dosing Week 48 (n:15)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	11.49	12.01	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
4.32
value
7.63
title
Prior to dosing at Week 2 (n:43)
categories
measurements
group Id
OG000
spread
4.35
value
7.72
title
Prior to dosing Week 4 (n:44)
categories
measurements
group Id
OG000
spread
6.75
value
8.79
title
Prior to dosing Week 12 (n:49)
categories
measurements
group Id
OG000
spread
8.83
value
9.37
title
Prior to dosing Week 24 (n:46)
categories
measurements
group Id
OG000
spread
12.01
value
11.49
title
Prior to dosing Week 48 (n:15)

denoms

counts
group Id
OG000
value
79
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Study drug was given by continuous oral daily dosing of two 5 mg tablets.
id
OG000
title
Everolimus Randomized (Core Period)

param Type

MEAN

population Description

The analysis was performed in the Safety Set population for patients treated only with Everolimus and with a confirmed PK sample.

reporting Status

POSTED

time Frame

Prior to dosing at weeks 2, 4, 12, 24, 48

title

Everolimus Trough Concentrations (Cmin)

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice