NCT01750697 · ADVERSE EVENTS

Adverse events

A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2019-06-26

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: Up to approximately 5 years
Other-event reporting threshold: 5%

The safety population included all participants who received at least part of one infusion of rituximab.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Remission Induction Phase: Rituximab Participants received rituximab as an IV infusion of 375 mg/m\^2 once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6)	7 / 25	22 / 25	0 / 25
Overall Follow-up Phase: Rituximab Participants who received rituximab during the remission induction phase were followed for a minimum of 18 months during the follow-up phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs)	12 / 25	24 / 25	0 / 25

Group identifiers: EG000: Remission Induction Phase: Rituximab · EG001: Overall Follow-up Phase: Rituximab

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 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Sickle cell anaemia with crisis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Sickle cell anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Anti-neutrophil cytoplasmic antibody positive vasculitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Device related sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Eye infection bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Gastroenteritis norovirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Gastroenteritis viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Infusion related reaction

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 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Deafness unilateral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
25
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
7
num At Risk
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
4
num At Risk
25
group Id
EG001
num Affected
5
num At Risk
25
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Hypogammaglobulinaemia

Complete source fields

description

The safety population included all participants who received at least part of one infusion of rituximab.

event Groups

deaths Num Affected
0
deaths Num At Risk
25
description
Participants received rituximab as an IV infusion of 375 mg/m\^2 once a week on Days 1, 8, 15 and 22 during Remission Induction Phase (Day 1 (baseline) to Month 6)
id
EG000
other Num Affected
22
other Num At Risk
25
serious Num Affected
7
serious Num At Risk
25
title
Remission Induction Phase: Rituximab
deaths Num Affected
0
deaths Num At Risk
25
description
Participants who received rituximab during the remission induction phase were followed for a minimum of 18 months during the follow-up phase and could receive additional rituximab or other treatments for GPA/MPA (Day 1 (baseline) up to 4.5 yrs)
id
EG001
other Num Affected
24
other Num At Risk
25
serious Num Affected
12
serious Num At Risk
25
title
Overall Follow-up Phase: Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Deafness unilateral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
25
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
3
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
7
num At Risk
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Gastritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
4
num At Risk
25
group Id
EG001
num Affected
5
num At Risk
25
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
4
num At Risk
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
2
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Non-cardiac chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
3
num At Risk
25
term
Hypogammaglobulinaemia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Sickle cell anaemia with crisis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Congenital, familial and genetic disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Sickle cell anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Pancreatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Anti-neutrophil cytoplasmic antibody positive vasculitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Device related sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Eye infection bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Gastroenteritis norovirus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Gastroenteritis viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
2
num At Risk
25
term
Lower respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
0
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 20.1
stats
group Id
EG000
num Affected
1
num At Risk
25
group Id
EG001
num Affected
1
num At Risk
25
term
Infusion related reaction

time Frame

Up to approximately 5 years

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Preserved source evidence · Not medical advice