NCT00721123 · ADVERSE EVENTS

Adverse events

A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis · Source last updated 2013-11-28

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: Not reported
Other-event reporting threshold: 5%

All-exposure population: All patients who entered the study and received at least 1 dose of tocilizumab at any time.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tocilizumab 8 mg/kg Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.	199 / 538	475 / 538	Not reported / Not reported

Group identifiers: EG000: Tocilizumab 8 mg/kg

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 (15.0)
stats
group Id
EG000
num Affected
12
num At Risk
538
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
5
num At Risk
538
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
4
num At Risk
538
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
4
num At Risk
538
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
4
num At Risk
538
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
2
num At Risk
538
term
Cellulitis staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
2
num At Risk
538
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
2
num At Risk
538
term
Pneumonia pneumococcal

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
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
136
num At Risk
538
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
133
num At Risk
538
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
93
num At Risk
538
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
83
num At Risk
538
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
69
num At Risk
538
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
60
num At Risk
538
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
43
num At Risk
538
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
37
num At Risk
538
term
Oral herpes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
32
num At Risk
538
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
31
num At Risk
538
term
Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
85
num At Risk
538
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
85
num At Risk
538
term
Dyspepsia

Complete source fields

description

All-exposure population: All patients who entered the study and received at least 1 dose of tocilizumab at any time.

event Groups

description
Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
id
EG000
other Num Affected
475
other Num At Risk
538
serious Num Affected
199
serious Num At Risk
538
title
Tocilizumab 8 mg/kg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
136
num At Risk
538
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
133
num At Risk
538
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
93
num At Risk
538
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
83
num At Risk
538
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
69
num At Risk
538
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
60
num At Risk
538
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
43
num At Risk
538
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
37
num At Risk
538
term
Oral herpes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
32
num At Risk
538
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
31
num At Risk
538
term
Rhinitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
85
num At Risk
538
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
85
num At Risk
538
term
Dyspepsia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
12
num At Risk
538
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
5
num At Risk
538
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
4
num At Risk
538
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
4
num At Risk
538
term
Erysipelas
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
4
num At Risk
538
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Bronchopneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
3
num At Risk
538
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
2
num At Risk
538
term
Cellulitis staphylococcal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
2
num At Risk
538
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (15.0)
stats
group Id
EG000
num Affected
2
num At Risk
538
term
Pneumonia pneumococcal

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