NCT00515203 · ADVERSE EVENTS

Adverse events

Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects · Source last updated 2014-07-25

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: 12 week treatment period
Other-event reporting threshold: 5%

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Not reported	0 / 5	5 / 5	Not reported / Not reported
Romiplostim Not reported	1 / 17	16 / 17	Not reported / Not reported

Group identifiers: EG000: Placebo · EG001: Romiplostim

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 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Sepsis

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
3
num At Risk
17
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Chapped lips
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Toothache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
17
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Chest discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
17
term
Injection site haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
17
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
4
num At Risk
17
term
Pyrexia

Complete source fields

description

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

event Groups

id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Placebo
id
EG001
other Num Affected
16
other Num At Risk
17
serious Num Affected
1
serious Num At Risk
17
title
Romiplostim

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
3
num At Risk
17
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Chapped lips
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Toothache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
2
num At Risk
5
group Id
EG001
num Affected
2
num At Risk
17
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Chest discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
17
term
Injection site haematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
1
num At Risk
5
group Id
EG001
num Affected
0
num At Risk
17
term
Malaise
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
4
num At Risk
17
term
Pyrexia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 11.0
stats
group Id
EG000
num Affected
0
num At Risk
5
group Id
EG001
num Affected
1
num At Risk
17
term
Sepsis

time Frame

12 week treatment period

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Preserved source evidence · Not medical advice