Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex · Source last updated 2014-10-20
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
During the entire study
Groups in this outcome
Everolimus
This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
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
28
Reported measurements
Upper Respiratory Tract Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
26
Not reported
Not reported
Not reported
Not reported
Stomatitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
25
Not reported
Not reported
Not reported
Not reported
Sinusitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
15
Not reported
Not reported
Not reported
Not reported
Mouth Ulceration
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
14
Not reported
Not reported
Not reported
Not reported
Cellulitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
12
Not reported
Not reported
Not reported
Not reported
Diarrhoea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
12
Not reported
Not reported
Not reported
Not reported
Gastroenteritis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
12
Not reported
Not reported
Not reported
Not reported
Otitis Media
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
11
Not reported
Not reported
Not reported
Not reported
Pyrexia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
10
Not reported
Not reported
Not reported
Not reported
Vomiting
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
10
Not reported
Not reported
Not reported
Not reported
Acne
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
9
Not reported
Not reported
Not reported
Not reported
Convulsion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
9
Not reported
Not reported
Not reported
Not reported
Nasopharyngitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
9
Not reported
Not reported
Not reported
Not reported
Rhinitis Allergic
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
9
Not reported
Not reported
Not reported
Not reported
Conjunctivitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
8
Not reported
Not reported
Not reported
Not reported
Pharyngitis
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
8
Not reported
Not reported
Not reported
Not reported
Rash
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
8
Not reported
Not reported
Not reported
Not reported
Constipation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Cough
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Dermatitis Acneiform
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Dermatitis Contact
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Excoriation
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Laceration
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Nasal Congestion
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Otitis Externa
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
7
Not reported
Not reported
Not reported
Not reported
Abnormal Behaviour
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
6
Not reported
Not reported
Not reported
Not reported
Body Tinea
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
6
Not reported
Not reported
Not reported
Not reported
Dry Skin
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
6
Not reported
Not reported
Not reported
Not reported
Pneumonia
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
6
Not reported
Not reported
Not reported
Not reported
Skin Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
6
Not reported
Not reported
Not reported
Not reported
Urinary Tract Infection
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Everolimus
6
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
26
title
Upper Respiratory Tract Infection
categories
measurements
group Id
OG000
value
25
title
Stomatitis
categories
measurements
group Id
OG000
value
15
title
Sinusitis
categories
measurements
group Id
OG000
value
14
title
Mouth Ulceration
categories
measurements
group Id
OG000
value
12
title
Cellulitis
categories
measurements
group Id
OG000
value
12
title
Diarrhoea
categories
measurements
group Id
OG000
value
12
title
Gastroenteritis
categories
measurements
group Id
OG000
value
11
title
Otitis Media
categories
measurements
group Id
OG000
value
10
title
Pyrexia
categories
measurements
group Id
OG000
value
10
title
Vomiting
categories
measurements
group Id
OG000
value
9
title
Acne
categories
measurements
group Id
OG000
value
9
title
Convulsion
denoms
counts
group Id
OG000
value
28
units
Participants
groups
description
This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
Triangle