NCT00088881 · ADVERSE EVENTS

Adverse events

Rituximab, Combination Chemotherapy, and 90-Yttrium Ibritumomab Tiuxetan for Patients With Stage I or II Non-Hodgkin's Lymphoma · Source last updated 2017-05-25

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: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Step 1 - R-CHOP Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.	44 / 62	62 / 62	Not reported / Not reported
Step 2 - Zevalin™ Radioimmunotherapy Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.	46 / 56	55 / 56	Not reported / Not reported
Step 3 - Radiation Therapy Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.	0 / 1	0 / 1	Not reported / Not reported

Group identifiers: EG000: Step 1 - R-CHOP · EG001: Step 2 - Zevalin™ Radioimmunotherapy · EG002: Step 3 - Radiation Therapy

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
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
CD4 decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
22
num At Risk
62
group Id
EG001
num Affected
20
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Leukocytes decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
26
num At Risk
62
group Id
EG001
num Affected
34
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
27
num At Risk
62
group Id
EG001
num Affected
29
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Neutrophils decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
26
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Platelets decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Heart block Stokes-Adams syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
7
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Nail changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
4
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Anorexia

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
CTCAE 3.0
stats
group Id
EG000
num Affected
48
num At Risk
62
group Id
EG001
num Affected
44
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
39
num At Risk
62
group Id
EG001
num Affected
51
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Leukocytes decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
50
num At Risk
62
group Id
EG001
num Affected
47
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
28
num At Risk
62
group Id
EG001
num Affected
41
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Neutrophils decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
20
num At Risk
62
group Id
EG001
num Affected
51
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Platelets decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
50
num At Risk
62
group Id
EG001
num Affected
32
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
6
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
7
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Rigors/chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Sweating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
11
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
31
num At Risk
62
group Id
EG001
num Affected
7
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Alopecia

Complete source fields

event Groups

description
Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
id
EG000
other Num Affected
62
other Num At Risk
62
serious Num Affected
44
serious Num At Risk
62
title
Step 1 - R-CHOP
description
Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
id
EG001
other Num Affected
55
other Num At Risk
56
serious Num Affected
46
serious Num At Risk
56
title
Step 2 - Zevalin™ Radioimmunotherapy
description
Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
id
EG002
other Num Affected
0
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Step 3 - Radiation Therapy

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
48
num At Risk
62
group Id
EG001
num Affected
44
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
39
num At Risk
62
group Id
EG001
num Affected
51
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Leukocytes decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
50
num At Risk
62
group Id
EG001
num Affected
47
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
28
num At Risk
62
group Id
EG001
num Affected
41
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Neutrophils decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
20
num At Risk
62
group Id
EG001
num Affected
51
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Platelets decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
50
num At Risk
62
group Id
EG001
num Affected
32
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Fever w/o neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
6
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Insomnia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
7
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Rigors/chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Sweating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
11
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Weight loss
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
31
num At Risk
62
group Id
EG001
num Affected
7
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Alopecia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
1
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
CD4 decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
3
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
22
num At Risk
62
group Id
EG001
num Affected
20
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Leukocytes decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
26
num At Risk
62
group Id
EG001
num Affected
34
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
27
num At Risk
62
group Id
EG001
num Affected
29
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Neutrophils decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
5
num At Risk
62
group Id
EG001
num Affected
26
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Platelets decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
0
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Heart block Stokes-Adams syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
7
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
1
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Nail changes
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE 3.0
stats
group Id
EG000
num Affected
4
num At Risk
62
group Id
EG001
num Affected
0
num At Risk
56
group Id
EG002
num Affected
0
num At Risk
1
term
Anorexia

time Frame

Assessed every 3 weeks while on treatment and for 30 days after the end of treatment

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Preserved source evidence · Not medical advice