NCT00411619 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Adverse events were collected throughout the course of the study, which was open for seven years.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Everolimus This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.	9 / 28	28 / 28	Not reported / Not reported

Group identifiers: EG000: Everolimus

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Abscess Limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Convulsion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Bronchitis Viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Pain In Extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Petechiae
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Post Lumbar Puncture Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Sudden Unexplained Death In Epilepsy

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
26
num At Risk
28
num Events
26
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
15
num At Risk
28
num Events
15
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
12
num At Risk
28
num Events
12
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
12
num At Risk
28
num Events
12
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
11
term
Otitis media
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
9
num At Risk
28
num Events
9
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
8
num At Risk
28
num Events
8
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
7
term
Otitis Externa
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
6
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
6
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
6
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
25
num At Risk
28
num Events
25
term
Stomatitis

Complete source fields

event Groups

description
This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
id
EG000
other Num Affected
28
other Num At Risk
28
serious Num Affected
9
serious Num At Risk
28
title
Everolimus

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
26
num At Risk
28
num Events
26
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
15
num At Risk
28
num Events
15
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
12
num At Risk
28
num Events
12
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
12
num At Risk
28
num Events
12
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
11
num At Risk
28
num Events
11
term
Otitis media
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
9
num At Risk
28
num Events
9
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
8
num At Risk
28
num Events
8
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
7
num At Risk
28
num Events
7
term
Otitis Externa
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
6
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
6
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
6
num At Risk
28
num Events
6
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
25
num At Risk
28
num Events
25
term
Stomatitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Abscess Limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
28
num Events
2
term
Convulsion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Bronchitis Viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Pain In Extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Petechiae
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Post Lumbar Puncture Syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
1
num At Risk
28
num Events
1
term
Sudden Unexplained Death In Epilepsy

time Frame

Adverse events were collected throughout the course of the study, which was open for seven years.

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Preserved source evidence · Not medical advice