NCT00299104 · ADVERSE EVENTS

Adverse events

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis · Source last updated 2017-07-28

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: From Baseline to End of ESFU
Other-event reporting threshold: 5%

Safety Population includes all participants who received at least one dose of study drug, grouped as treated. After Week 104 participants in the placebo group were eligible to receive either Rituximab 2 X 0.5 g + MTX or Rituximab 2 X 1.0g + MTX. Adverse events reported for placebo patients after switching to Rituximab are not included below.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Placebo + Methotrexate Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.	48 / 249	193 / 249	Not reported / Not reported
Rituximab (0.5 g x 2) + Methotrexate Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6	54 / 348	232 / 348	Not reported / Not reported
Rituximab (1.0 g x 2) + Methotrexate Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6	58 / 263	208 / 263	Not reported / Not reported

Group identifiers: EG000: Placebo + Methotrexate · EG001: Rituximab (0.5 g x 2) + Methotrexate · EG002: Rituximab (1.0 g x 2) + 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
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
6
num At Risk
249
group Id
EG001
num Affected
7
num At Risk
348
group Id
EG002
num Affected
4
num At Risk
263
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
4
num At Risk
249
group Id
EG001
num Affected
2
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Urinary Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
2
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Appendicitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
249
group Id
EG001
num Affected
0
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Acute Tonsillitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
1
num At Risk
263
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
249
group Id
EG001
num Affected
0
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Febrile Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
1
num At Risk
263
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
0
num At Risk
348
group Id
EG002
num Affected
3
num At Risk
263
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Lung Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Pneumocystis Jirovecii Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Pneumonia Pneumococcal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Septic Shock

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
53
num At Risk
249
group Id
EG001
num Affected
69
num At Risk
348
group Id
EG002
num Affected
67
num At Risk
263
term
Infusion Related Reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
42
num At Risk
249
group Id
EG001
num Affected
45
num At Risk
348
group Id
EG002
num Affected
46
num At Risk
263
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
44
num At Risk
249
group Id
EG001
num Affected
59
num At Risk
348
group Id
EG002
num Affected
58
num At Risk
263
term
Upper Respiratory Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
43
num At Risk
249
group Id
EG001
num Affected
53
num At Risk
348
group Id
EG002
num Affected
52
num At Risk
263
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
42
num At Risk
249
group Id
EG001
num Affected
30
num At Risk
348
group Id
EG002
num Affected
29
num At Risk
263
term
Rheumatoid Arthritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
26
num At Risk
249
group Id
EG001
num Affected
36
num At Risk
348
group Id
EG002
num Affected
43
num At Risk
263
term
Urinary Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
18
num At Risk
249
group Id
EG001
num Affected
17
num At Risk
348
group Id
EG002
num Affected
31
num At Risk
263
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
25
num At Risk
249
group Id
EG001
num Affected
14
num At Risk
348
group Id
EG002
num Affected
19
num At Risk
263
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
18
num At Risk
249
group Id
EG001
num Affected
22
num At Risk
348
group Id
EG002
num Affected
24
num At Risk
263
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
249
group Id
EG001
num Affected
24
num At Risk
348
group Id
EG002
num Affected
18
num At Risk
263
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
249
group Id
EG001
num Affected
32
num At Risk
348
group Id
EG002
num Affected
20
num At Risk
263
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
13
num At Risk
249
group Id
EG001
num Affected
12
num At Risk
348
group Id
EG002
num Affected
20
num At Risk
263
term
Dizziness

Complete source fields

description

event Groups

description
Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks.
id
EG000
other Num Affected
193
other Num At Risk
249
serious Num Affected
48
serious Num At Risk
249
title
Placebo + Methotrexate
description
Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
id
EG001
other Num Affected
232
other Num At Risk
348
serious Num Affected
54
serious Num At Risk
348
title
Rituximab (0.5 g x 2) + Methotrexate
description
Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8. Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6
id
EG002
other Num Affected
208
other Num At Risk
263
serious Num Affected
58
serious Num At Risk
263
title
Rituximab (1.0 g x 2) + Methotrexate

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
53
num At Risk
249
group Id
EG001
num Affected
69
num At Risk
348
group Id
EG002
num Affected
67
num At Risk
263
term
Infusion Related Reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
42
num At Risk
249
group Id
EG001
num Affected
45
num At Risk
348
group Id
EG002
num Affected
46
num At Risk
263
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
44
num At Risk
249
group Id
EG001
num Affected
59
num At Risk
348
group Id
EG002
num Affected
58
num At Risk
263
term
Upper Respiratory Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
43
num At Risk
249
group Id
EG001
num Affected
53
num At Risk
348
group Id
EG002
num Affected
52
num At Risk
263
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
42
num At Risk
249
group Id
EG001
num Affected
30
num At Risk
348
group Id
EG002
num Affected
29
num At Risk
263
term
Rheumatoid Arthritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
26
num At Risk
249
group Id
EG001
num Affected
36
num At Risk
348
group Id
EG002
num Affected
43
num At Risk
263
term
Urinary Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
18
num At Risk
249
group Id
EG001
num Affected
17
num At Risk
348
group Id
EG002
num Affected
31
num At Risk
263
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
25
num At Risk
249
group Id
EG001
num Affected
14
num At Risk
348
group Id
EG002
num Affected
19
num At Risk
263
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
18
num At Risk
249
group Id
EG001
num Affected
22
num At Risk
348
group Id
EG002
num Affected
24
num At Risk
263
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
249
group Id
EG001
num Affected
24
num At Risk
348
group Id
EG002
num Affected
18
num At Risk
263
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
15
num At Risk
249
group Id
EG001
num Affected
32
num At Risk
348
group Id
EG002
num Affected
20
num At Risk
263
term
Bronchitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
13
num At Risk
249
group Id
EG001
num Affected
12
num At Risk
348
group Id
EG002
num Affected
20
num At Risk
263
term
Dizziness

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
6
num At Risk
249
group Id
EG001
num Affected
7
num At Risk
348
group Id
EG002
num Affected
4
num At Risk
263
term
Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
4
num At Risk
249
group Id
EG001
num Affected
2
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Urinary Tract Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
2
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Appendicitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
249
group Id
EG001
num Affected
0
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Acute Tonsillitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
1
num At Risk
263
term
Cellulitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
1
num At Risk
249
group Id
EG001
num Affected
0
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Febrile Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
1
num At Risk
263
term
Gastroenteritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
0
num At Risk
348
group Id
EG002
num Affected
3
num At Risk
263
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Lung Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Pneumocystis Jirovecii Pneumonia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Pneumonia Pneumococcal
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 16.0
stats
group Id
EG000
num Affected
0
num At Risk
249
group Id
EG001
num Affected
1
num At Risk
348
group Id
EG002
num Affected
0
num At Risk
263
term
Septic Shock

time Frame

From Baseline to End of ESFU

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Preserved source evidence · Not medical advice