NCT00438880 · ADVERSE EVENTS

Adverse events

Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma · Source last updated 2016-02-04

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15	14 / 30	30 / 30	Not reported / Not reported
Phase II Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15	5 / 8	8 / 8	Not reported / Not reported

Group identifiers: EG000: Phase I · EG001: Phase II

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 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
30
num Events
7
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Leukocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
10
num At Risk
30
num Events
11
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
12
num At Risk
30
num Events
20
group Id
EG001
num Affected
4
num At Risk
8
num Events
7
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Tumor pain

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 6
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
40
group Id
EG001
num Affected
8
num At Risk
8
num Events
15
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
5
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Localized edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
3
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Alanine aminotransferase increased

Complete source fields

event Groups

description
Phase I patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1 * 10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
id
EG000
other Num Affected
30
other Num At Risk
30
serious Num Affected
14
serious Num At Risk
30
title
Phase I
description
Phase II patients will receive the following treatment: * 250 mg/m\^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle * 5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8 * 0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle. * 0.4 mCi/kg Yttrium-90 Zevalin IV on day 15
id
EG001
other Num Affected
8
other Num At Risk
8
serious Num Affected
5
serious Num At Risk
8
title
Phase II

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
19
num At Risk
30
num Events
40
group Id
EG001
num Affected
8
num At Risk
8
num Events
15
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
30
num Events
5
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Localized edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Abdominal infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
3
num At Risk
30
num Events
3
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Sinusitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Alanine aminotransferase increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
30
num Events
1
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
30
num Events
7
group Id
EG001
num Affected
0
num At Risk
8
num Events
0
term
Leukocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
10
num At Risk
30
num Events
11
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
12
num At Risk
30
num Events
20
group Id
EG001
num Affected
4
num At Risk
8
num Events
7
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
30
num Events
0
group Id
EG001
num Affected
1
num At Risk
8
num Events
1
term
Tumor pain

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