NCT00790400 · OUTCOME

Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose

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: 2 hours post-dose administration at Weeks 2, 4, 12, 24, 48

What was measured

C2h values collected 1-3 hours after dose administration on the same study day, at steady state, and patient did not vomit between taking previous dose and blood collection. Samples collected during the first 4 days of dosing will be 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

2 hours post dose administration at Week 2 (n:55)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	33.38	15.66	Not reported	Not reported	Not reported

2 hours post dose administration at Week 4 (n:49)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	30.89	14.96	Not reported	Not reported	Not reported

2 hours post dose administration at Week 12 (n:56)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	34.48	15.10	Not reported	Not reported	Not reported

2 hours post dose administration at Week 24 (n:50)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	39.27	22.25	Not reported	Not reported	Not reported

2 hours post dose administration at Week 48 (n:14)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus Randomized (Core Period)	33.20	18.45	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
15.66
value
33.38
title
2 hours post dose administration at Week 2 (n:55)
categories
measurements
group Id
OG000
spread
14.96
value
30.89
title
2 hours post dose administration at Week 4 (n:49)
categories
measurements
group Id
OG000
spread
15.10
value
34.48
title
2 hours post dose administration at Week 12 (n:56)
categories
measurements
group Id
OG000
spread
22.25
value
39.27
title
2 hours post dose administration at Week 24 (n:50)
categories
measurements
group Id
OG000
spread
18.45
value
33.20
title
2 hours post dose administration at Week 48 (n:14)

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

2 hours post-dose administration at Weeks 2, 4, 12, 24, 48

title

Everolimus Blood Concentrations (C2h) at 2 Hours Post-dose

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice