NCT01143038 · ADVERSE EVENTS

Adverse events

Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim · Source last updated 2022-09-21

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: From first dose date of romiplostim to end of study (up to 24 months).
Other-event reporting threshold: 5%

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Romiplostim Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.	17 / 75	50 / 75	Not reported / Not reported

Group identifiers: EG000: 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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Idiopathic Thrombocytopenic Purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Tendon Rupture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Transaminases Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Non-Hodgkin's Lymphoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Papillary Thyroid Cancer

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
Ear and labyrinth disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
5
num At Risk
75
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
75
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
7
num At Risk
75
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
10
num At Risk
75
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
75
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
11
num At Risk
75
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Dizziness

Complete source fields

description

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

event Groups

description
Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10\^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10\^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10\^9/L could reinitiate romiplostim for up to 8 weeks.
id
EG000
other Num Affected
50
other Num At Risk
75
serious Num Affected
17
serious Num At Risk
75
title
Romiplostim

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Conjunctivitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
5
num At Risk
75
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
75
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
7
num At Risk
75
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
10
num At Risk
75
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
6
num At Risk
75
term
Upper Respiratory Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
11
num At Risk
75
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Myalgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
4
num At Risk
75
term
Dizziness

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Idiopathic Thrombocytopenic Purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Atrial Fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Abdominal Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Faecaloma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Tendon Rupture
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Transaminases Increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Non-Hodgkin's Lymphoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 16.1
stats
group Id
EG000
num Affected
1
num At Risk
75
term
Papillary Thyroid Cancer

time Frame

From first dose date of romiplostim to end of study (up to 24 months).

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