NCT01613599 · ADVERSE EVENTS

Adverse events

An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis · Source last updated 2018-07-26

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: Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years	38 / 97	5 / 97	9 / 97

Group identifiers: EG000: 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
Infections and infestations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Staphylococcal bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Endocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Pneumonia bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Pneumonia legionella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
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
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
5
num At Risk
97
term
Throat irritation

Complete source fields

event Groups

deaths Num Affected
9
deaths Num At Risk
97
description
Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4.32 years
id
EG000
other Num Affected
5
other Num At Risk
97
serious Num Affected
38
serious Num At Risk
97
title
Rituximab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
5
num At Risk
97
term
Throat irritation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 18.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Staphylococcal bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Endocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
2
num At Risk
97
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Pneumonia bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Pneumonia legionella
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 20.0
stats
group Id
EG000
num Affected
1
num At Risk
97
term
Sepsis

time Frame

Enrollment of the first participant to time of withdrawal or last participant visit (Up to 4.32 years)

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Preserved source evidence · Not medical advice