NCT00517699 · ADVERSE EVENTS

Adverse events

A Study of MabThera (Rituximab) in Primary Central Nervous System Lymphoma. · Source last updated 2014-08-08

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: Baseline up to 24 weeks.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab, Cytarabine, and MTX Participants received single doses of rituximab 750 mg/m\^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m\^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m\^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.	0 / 5	5 / 5	Not reported / Not reported

Group identifiers: EG000: Rituximab, Cytarabine, and MTX

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

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
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
5
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Eye allergy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Gingival pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Vomiting

Complete source fields

event Groups

description
Participants received single doses of rituximab 750 mg/m\^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m\^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m\^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
id
EG000
other Num Affected
5
other Num At Risk
5
serious Num Affected
0
serious Num At Risk
5
title
Rituximab, Cytarabine, and MTX

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Anaemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Leukopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
4
num At Risk
5
term
Neutropenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Eye allergy
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Abdominal pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Constipation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Diarrhoea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Dyspepsia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
1
num At Risk
5
term
Gingival pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
3
num At Risk
5
term
Nausea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (9.0)
stats
group Id
EG000
num Affected
2
num At Risk
5
term
Vomiting

time Frame

Baseline up to 24 weeks.

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Preserved source evidence · Not medical advice