NCT00719472 · ADVERSE EVENTS

Adverse events

A Study of Rituximab Alternative Dosing Rate in Patients With Previously Untreated Diffuse Large B-cell or Follicular Non-Hodgkin's Lymphoma (RATE) · Source last updated 2017-05-15

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: Adverse events and serious adverse events were recorded from the start of study treatment until 30 days following the last administration of study treatment or at study discontinuation/early termination, whichever occurred earlier.
Other-event reporting threshold: 5%

Adverse events are reported for the intent-to-treat (ITT) population which included all patients who received at least 1 dose of rituximab, regardless of infusion rate.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Rituximab 375 mg/m^2 Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.	107 / 425	421 / 425	Not reported / Not reported

Group identifiers: EG000: Rituximab 375 mg/m^2

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 (14.0)
stats
group Id
EG000
num Affected
33
num At Risk
425
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
10
num At Risk
425
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
7
num At Risk
425
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
5
num At Risk
425
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
425
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
425
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
3
num At Risk
425
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
3
num At Risk
425
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Acute myocardial infarction

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 (14.0)
stats
group Id
EG000
num Affected
135
num At Risk
425
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
100
num At Risk
425
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
55
num At Risk
425
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
31
num At Risk
425
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
202
num At Risk
425
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
69
num At Risk
425
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
142
num At Risk
425
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
99
num At Risk
425
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
43
num At Risk
425
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
51
num At Risk
425
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
34
num At Risk
425
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
37
num At Risk
425
term
Dry mouth

Complete source fields

description

Adverse events are reported for the intent-to-treat (ITT) population which included all patients who received at least 1 dose of rituximab, regardless of infusion rate.

event Groups

description
Patients received 6 or 8 21-day cycles of CHOP (cyclophosphamide, hydroxydaunorubicin \[doxorubicin\], Oncovin \[vincristine\], prednisone) or CVP (cyclophosphamide, vincristine, prednisone) in combination with rituximab 375 mg/m\^2 administered by intravenous (IV) infusion on Day 1 of each cycle.
id
EG000
other Num Affected
421
other Num At Risk
425
serious Num Affected
107
serious Num At Risk
425
title
Rituximab 375 mg/m^2

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
135
num At Risk
425
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
100
num At Risk
425
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
55
num At Risk
425
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
31
num At Risk
425
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
202
num At Risk
425
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
69
num At Risk
425
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
142
num At Risk
425
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
99
num At Risk
425
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
43
num At Risk
425
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
51
num At Risk
425
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
34
num At Risk
425
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
37
num At Risk
425
term
Dry mouth

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
33
num At Risk
425
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
10
num At Risk
425
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
7
num At Risk
425
term
Pancytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
5
num At Risk
425
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
425
term
Cardiac arrest
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
2
num At Risk
425
term
Ventricular tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
3
num At Risk
425
term
Cardiac failure congestive
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
3
num At Risk
425
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Cardiomyopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (14.0)
stats
group Id
EG000
num Affected
1
num At Risk
425
term
Acute myocardial infarction

time Frame

Adverse events and serious adverse events were recorded from the start of study treatment until 30 days following the last administration of study treatment or at study discontinuation/early termination, whichever occurred earlier.

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