NCT00468546 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy · Source last updated 2016-10-25

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 Week 104
Other-event reporting threshold: 5%

Adverse events were captured in safety analysis population. Safety population included participants who were randomized and received any part of an infusion of the study drug.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo Plus Methotrexate Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.	26 / 208	152 / 208	Not reported / Not reported
Rituximab Plus Methotrexate Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.	50 / 308	225 / 308	Not reported / Not reported

Group identifiers: EG000: Placebo Plus Methotrexate · EG001: Rituximab Plus Methotrexate

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
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
5
num At Risk
208
group Id
EG001
num Affected
6
num At Risk
308
term
Rheumatoid arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
2
num At Risk
308
term
Osteoarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
1
num At Risk
208
group Id
EG001
num Affected
0
num At Risk
308
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
1
num At Risk
208
group Id
EG001
num Affected
0
num At Risk
308
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Bursitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Cervical spinal stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Intervertebral disc degeneration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Intervertebral disc protrusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Monarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
1
num At Risk
208
group Id
EG001
num Affected
0
num At Risk
308
term
Neck pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Polyarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
3
num At Risk
308
term
Pneumonia

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
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
87
num At Risk
208
group Id
EG001
num Affected
106
num At Risk
308
term
Rheumatoid Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
8
num At Risk
208
group Id
EG001
num Affected
24
num At Risk
308
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
10
num At Risk
208
group Id
EG001
num Affected
16
num At Risk
308
term
Back Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
17
num At Risk
208
group Id
EG001
num Affected
36
num At Risk
308
term
Upper Respiratory Tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
15
num At Risk
208
group Id
EG001
num Affected
30
num At Risk
308
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
15
num At Risk
208
group Id
EG001
num Affected
25
num At Risk
308
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
15
num At Risk
208
group Id
EG001
num Affected
21
num At Risk
308
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
14
num At Risk
208
group Id
EG001
num Affected
12
num At Risk
308
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
21
num At Risk
208
group Id
EG001
num Affected
31
num At Risk
308
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
8
num At Risk
208
group Id
EG001
num Affected
16
num At Risk
308
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
18
num At Risk
208
group Id
EG001
num Affected
21
num At Risk
308
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
8
num At Risk
208
group Id
EG001
num Affected
23
num At Risk
308
term
Nausea

Complete source fields

description

Adverse events were captured in safety analysis population. Safety population included participants who were randomized and received any part of an infusion of the study drug.

event Groups

description
Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
id
EG000
other Num Affected
152
other Num At Risk
208
serious Num Affected
26
serious Num At Risk
208
title
Placebo Plus Methotrexate
description
Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
id
EG001
other Num Affected
225
other Num At Risk
308
serious Num Affected
50
serious Num At Risk
308
title
Rituximab Plus Methotrexate

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
87
num At Risk
208
group Id
EG001
num Affected
106
num At Risk
308
term
Rheumatoid Arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
8
num At Risk
208
group Id
EG001
num Affected
24
num At Risk
308
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
10
num At Risk
208
group Id
EG001
num Affected
16
num At Risk
308
term
Back Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
17
num At Risk
208
group Id
EG001
num Affected
36
num At Risk
308
term
Upper Respiratory Tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
15
num At Risk
208
group Id
EG001
num Affected
30
num At Risk
308
term
Nasopharyngitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
15
num At Risk
208
group Id
EG001
num Affected
25
num At Risk
308
term
Bronchitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
15
num At Risk
208
group Id
EG001
num Affected
21
num At Risk
308
term
Urinary Tract Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
14
num At Risk
208
group Id
EG001
num Affected
12
num At Risk
308
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
21
num At Risk
208
group Id
EG001
num Affected
31
num At Risk
308
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
8
num At Risk
208
group Id
EG001
num Affected
16
num At Risk
308
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
18
num At Risk
208
group Id
EG001
num Affected
21
num At Risk
308
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
8
num At Risk
208
group Id
EG001
num Affected
23
num At Risk
308
term
Nausea

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
5
num At Risk
208
group Id
EG001
num Affected
6
num At Risk
308
term
Rheumatoid arthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
2
num At Risk
308
term
Osteoarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
1
num At Risk
208
group Id
EG001
num Affected
0
num At Risk
308
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
1
num At Risk
208
group Id
EG001
num Affected
0
num At Risk
308
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Bursitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Cervical spinal stenosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Intervertebral disc degeneration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Intervertebral disc protrusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Monarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
1
num At Risk
208
group Id
EG001
num Affected
0
num At Risk
308
term
Neck pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
1
num At Risk
308
term
Polyarthritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
15.1
stats
group Id
EG000
num Affected
0
num At Risk
208
group Id
EG001
num Affected
3
num At Risk
308
term
Pneumonia

time Frame

Up to Week 104

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice