NCT00116688 · ADVERSE EVENTS

Adverse events

Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) · Source last updated 2013-12-18

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: For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks
Other-event reporting threshold: 5%

The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One adult patient and one pediatric patient did not receive the investigational product and were not included in the adverse event table.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Romiplostim in Adults Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.	117 / 291	270 / 291	Not reported / Not reported
Romiplostim in Pediatric Population Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.	2 / 20	18 / 20	Not reported / Not reported

Group identifiers: EG000: Romiplostim in Adults · EG001: Romiplostim in Pediatric Population

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Bicytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Bone marrow disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Bone marrow reticulin fibrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Evans syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
7
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Idiopathic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
23
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Angina unstable

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 12.0
stats
group Id
EG000
num Affected
17
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
29
num At Risk
291
group Id
EG001
num Affected
2
num At Risk
20
term
Idiopathic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
17
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
33
num At Risk
291
group Id
EG001
num Affected
3
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
21
num At Risk
291
group Id
EG001
num Affected
4
num At Risk
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
26
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
72
num At Risk
291
group Id
EG001
num Affected
2
num At Risk
20
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
19
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
43
num At Risk
291
group Id
EG001
num Affected
5
num At Risk
20
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
21
num At Risk
291
group Id
EG001
num Affected
4
num At Risk
20
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
291
group Id
EG001
num Affected
2
num At Risk
20
term
Mouth ulceration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
69
num At Risk
291
group Id
EG001
num Affected
4
num At Risk
20
term
Nausea

Complete source fields

description

event Groups

description
Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving \>10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to \>10 µg/kg.
id
EG000
other Num Affected
270
other Num At Risk
291
serious Num Affected
117
serious Num At Risk
291
title
Romiplostim in Adults
description
Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
id
EG001
other Num Affected
18
other Num At Risk
20
serious Num Affected
2
serious Num At Risk
20
title
Romiplostim in Pediatric Population

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
17
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
29
num At Risk
291
group Id
EG001
num Affected
2
num At Risk
20
term
Idiopathic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
17
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
33
num At Risk
291
group Id
EG001
num Affected
3
num At Risk
20
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
21
num At Risk
291
group Id
EG001
num Affected
4
num At Risk
20
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
26
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
72
num At Risk
291
group Id
EG001
num Affected
2
num At Risk
20
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
19
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
43
num At Risk
291
group Id
EG001
num Affected
5
num At Risk
20
term
Gingival bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
21
num At Risk
291
group Id
EG001
num Affected
4
num At Risk
20
term
Mouth haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
291
group Id
EG001
num Affected
2
num At Risk
20
term
Mouth ulceration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
69
num At Risk
291
group Id
EG001
num Affected
4
num At Risk
20
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Bicytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
4
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Bone marrow disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Bone marrow reticulin fibrosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Evans syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Haemolytic anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
7
num At Risk
291
group Id
EG001
num Affected
1
num At Risk
20
term
Idiopathic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Leukocytosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
23
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Acute myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
291
group Id
EG001
num Affected
0
num At Risk
20
term
Angina unstable

time Frame

For adult participants the average duration was 110 weeks; for pediatric participants the average duration is 82 weeks

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Preserved source evidence · Not medical advice