NCT00720798 · ADVERSE EVENTS

Adverse events

An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30

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 participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Tocilizumab Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.	727 / 2067	1836 / 2067	Not reported / Not reported

Group identifiers: EG000: Tocilizumab

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 (16.0)
stats
group Id
EG000
num Affected
70
num At Risk
2067
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
57
num At Risk
2067
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
11
num At Risk
2067
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
8
num At Risk
2067
term
Arthritis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
7
num At Risk
2067
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
7
num At Risk
2067
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
6
num At Risk
2067
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
6
num At Risk
2067
term
Erysipelas

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 (16.0)
stats
group Id
EG000
num Affected
616
num At Risk
2067
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
495
num At Risk
2067
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
420
num At Risk
2067
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
405
num At Risk
2067
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
326
num At Risk
2067
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
231
num At Risk
2067
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
213
num At Risk
2067
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
180
num At Risk
2067
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
129
num At Risk
2067
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
127
num At Risk
2067
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
122
num At Risk
2067
term
Gastroenteritis viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
358
num At Risk
2067
term
Diarrhoea

Complete source fields

description

All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.

event Groups

description
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
id
EG000
other Num Affected
1836
other Num At Risk
2067
serious Num Affected
727
serious Num At Risk
2067
title
Tocilizumab

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
616
num At Risk
2067
term
Upper respiratory tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
495
num At Risk
2067
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
420
num At Risk
2067
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
405
num At Risk
2067
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
326
num At Risk
2067
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
231
num At Risk
2067
term
Influenza
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
213
num At Risk
2067
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
180
num At Risk
2067
term
Pharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
129
num At Risk
2067
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
127
num At Risk
2067
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
122
num At Risk
2067
term
Gastroenteritis viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
358
num At Risk
2067
term
Diarrhoea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
70
num At Risk
2067
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
57
num At Risk
2067
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
11
num At Risk
2067
term
Appendicitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Diverticulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Gastroenteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
10
num At Risk
2067
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
8
num At Risk
2067
term
Arthritis bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
7
num At Risk
2067
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
7
num At Risk
2067
term
Herpes zoster
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
6
num At Risk
2067
term
Abscess limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (16.0)
stats
group Id
EG000
num Affected
6
num At Risk
2067
term
Erysipelas

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Preserved source evidence · Not medical advice