NCT01283542 · ADVERSE EVENTS

Adverse events

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma. · Source last updated 2019-04-26

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 (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 104 weeks
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pasireotide LAR All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks	2 / 20	17 / 20	0 / 20

Group identifiers: EG000: Pasireotide LAR

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
Hepatobiliary disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cholelithiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hand fracture

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
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
9
num At Risk
20
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Blood glucose increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Diabetes mellitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Dyslipidaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
9
num At Risk
20
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Type 2 diabetes mellitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Arthralgia

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
20
description
All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
id
EG000
other Num Affected
17
other Num At Risk
20
serious Num Affected
2
serious Num At Risk
20
title
Pasireotide LAR

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
9
num At Risk
20
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Blood glucose increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Diabetes mellitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Dyslipidaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
9
num At Risk
20
term
Hyperglycaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Type 2 diabetes mellitus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Arthralgia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cholelithiasis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA (20.0)
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hand fracture

time Frame

Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 104 weeks

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Preserved source evidence · Not medical advice