NCT00104299 · ADVERSE EVENTS

Adverse events

Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis · Source last updated 2017-04-21

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 randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)
Other-event reporting threshold: 5%

Adverse events reported include both disease and non-disease related events by originally assigned treatment. No participants are censored from these results. NCI-CTCAE version 3.0 (published June 10, 2003) was used to grade severity.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.	60 / 99	97 / 99	Not reported / Not reported
Control Group Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.	47 / 98	97 / 98	Not reported / Not reported

Group identifiers: EG000: Rituximab · EG001: Control Group

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
3
num At Risk
99
num Events
3
group Id
EG001
num Affected
4
num At Risk
98
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
99
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Autoimmune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
2
num At Risk
98
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
3
num At Risk
99
num Events
5
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
2
num At Risk
99
num Events
2
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
99
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Sudden hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
99
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Ulcerative keratitis

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
22
num At Risk
99
num Events
28
group Id
EG001
num Affected
18
num At Risk
98
num Events
23
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
13
num At Risk
99
num Events
30
group Id
EG001
num Affected
39
num At Risk
98
num Events
80
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
9
num At Risk
99
num Events
13
group Id
EG001
num Affected
5
num At Risk
98
num Events
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
7
num At Risk
99
num Events
8
group Id
EG001
num Affected
5
num At Risk
98
num Events
5
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
5
num At Risk
99
num Events
6
group Id
EG001
num Affected
6
num At Risk
98
num Events
6
term
Cushingoid
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
4
num At Risk
99
num Events
4
group Id
EG001
num Affected
7
num At Risk
98
num Events
7
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
27
num At Risk
99
num Events
35
group Id
EG001
num Affected
20
num At Risk
98
num Events
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
7
num At Risk
99
num Events
7
group Id
EG001
num Affected
8
num At Risk
98
num Events
8
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
10
num At Risk
99
num Events
10
group Id
EG001
num Affected
6
num At Risk
98
num Events
6
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
25
num At Risk
99
num Events
28
group Id
EG001
num Affected
31
num At Risk
98
num Events
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
8
num At Risk
99
num Events
12
group Id
EG001
num Affected
13
num At Risk
98
num Events
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
6
num At Risk
99
num Events
7
group Id
EG001
num Affected
4
num At Risk
98
num Events
4
term
Chest discomfort

Complete source fields

description

event Groups

description
Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled "Detailed Description" for additional treatment information.
id
EG000
other Num Affected
97
other Num At Risk
99
serious Num Affected
60
serious Num At Risk
99
title
Rituximab
description
Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled "Detailed Description" for additional treatment information.
id
EG001
other Num Affected
97
other Num At Risk
98
serious Num Affected
47
serious Num At Risk
98
title
Control Group

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
22
num At Risk
99
num Events
28
group Id
EG001
num Affected
18
num At Risk
98
num Events
23
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
13
num At Risk
99
num Events
30
group Id
EG001
num Affected
39
num At Risk
98
num Events
80
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
9
num At Risk
99
num Events
13
group Id
EG001
num Affected
5
num At Risk
98
num Events
6
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
7
num At Risk
99
num Events
8
group Id
EG001
num Affected
5
num At Risk
98
num Events
5
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
5
num At Risk
99
num Events
6
group Id
EG001
num Affected
6
num At Risk
98
num Events
6
term
Cushingoid
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
4
num At Risk
99
num Events
4
group Id
EG001
num Affected
7
num At Risk
98
num Events
7
term
Vision blurred
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
27
num At Risk
99
num Events
35
group Id
EG001
num Affected
20
num At Risk
98
num Events
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
7
num At Risk
99
num Events
7
group Id
EG001
num Affected
8
num At Risk
98
num Events
8
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
10
num At Risk
99
num Events
10
group Id
EG001
num Affected
6
num At Risk
98
num Events
6
term
Gastrooesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
25
num At Risk
99
num Events
28
group Id
EG001
num Affected
31
num At Risk
98
num Events
41
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
8
num At Risk
99
num Events
12
group Id
EG001
num Affected
13
num At Risk
98
num Events
18
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
6
num At Risk
99
num Events
7
group Id
EG001
num Affected
4
num At Risk
98
num Events
4
term
Chest discomfort

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
3
num At Risk
99
num Events
3
group Id
EG001
num Affected
4
num At Risk
98
num Events
6
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
99
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Autoimmune thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
2
num At Risk
98
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
3
num At Risk
99
num Events
5
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
2
num At Risk
99
num Events
2
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
99
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Supraventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Sudden hearing loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
99
num Events
1
group Id
EG001
num Affected
0
num At Risk
98
num Events
0
term
Keratitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
99
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Ulcerative keratitis

time Frame

From randomization through common close out (defined as 18 months after the last participant is enrolled in the trial)

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