NCT00244855 · ADVERSE EVENTS

Adverse events

Rituximab and Dexamethasone in Treating Patients With Low-Grade Non-Hodgkin Lymphoma · Source last updated 2017-05-22

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: 6 months
Other-event reporting threshold: 4%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Previous Treatment Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies	0 / 7	5 / 7	Not reported / Not reported
No Previous Treatment Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies	0 / 25	16 / 25	Not reported / Not reported

Group identifiers: EG000: Previous Treatment · EG001: No Previous Treatment

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
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Vasovagal episode
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Cytokine release syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
25
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Thrombosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Urticaria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Pruritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
25
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Penile infection

Complete source fields

event Groups

description
Patients received previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies
id
EG000
other Num Affected
5
other Num At Risk
7
serious Num Affected
0
serious Num At Risk
7
title
Previous Treatment
description
Patients received no previous treatment. Patients enrolled in the trial received dexamethasone IV and rituximab IV once weekly. Treatment continues for 4 weeks in the absence of disease progression or unacceptable toxicity. pharmacological study: Correlative studies rituximab: Given IV dexamethasone: Given IV laboratory biomarker analysis: Correlative studies
id
EG001
other Num Affected
16
other Num At Risk
25
serious Num Affected
0
serious Num At Risk
25
title
No Previous Treatment

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Vasovagal episode
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Hypertension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Hypotension
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Cytokine release syndrome
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
2
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
25
term
Lymphopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Thrombocytopenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Thrombosis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Urticaria
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Pruritis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
2
num At Risk
25
term
Allergic reaction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
7
group Id
EG001
num Affected
1
num At Risk
25
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
7
group Id
EG001
num Affected
0
num At Risk
25
term
Penile infection

time Frame

6 months

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Preserved source evidence · Not medical advice