NCT00577278 · ADVERSE EVENTS

Adverse events

A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan · Source last updated 2024-02-16

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: From initial treatment to off study, up to 5 years.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
0.4 mCi 90Y-Ibritumomab Tiuxetan Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV	28 / 41	41 / 41	24 / 41

Group identifiers: EG000: 0.4 mCi 90Y-Ibritumomab Tiuxetan

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 (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Chyle or lymph leakage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Hemorrhage, GI
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Hemorrhage, pulmonary/upper respiratory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Thrombosis/embolism (vascular access-related)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
num Events
4
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Pericardial effusion (non-malignant)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Ascites (non-malignant)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
term
Dehydration

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 (10.0)
stats
group Id
EG000
num Affected
14
num At Risk
41
num Events
20
term
Bone marrow cellularity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
DIC (disseminated intravascular coagulation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
19
num At Risk
41
num Events
21
term
Edema:head and neck
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
35
num At Risk
41
num Events
51
term
Edema:limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
num Events
5
term
Edema:trunk/genital
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
num Events
5
term
Haptoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
term
Hematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
41
num At Risk
41
num Events
126
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
num Events
9
term
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
22
num At Risk
41
num Events
31
term
Hemorrhage, GI
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
20
num At Risk
41
num Events
24
term
Hemorrhage, GU
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
20
num At Risk
41
num Events
22
term
Hemorrhage, pulmonary/upper respiratory

Complete source fields

event Groups

deaths Num Affected
24
deaths Num At Risk
41
description
Patients receive rituximab IV followed by indium In-111 ibritumomab tiuxetan IV over 10 minutes on day -21 and rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14. Patients also receive fludarabine phosphate IV on days -9 to -5 and melphalan IV on day -4. Patients undergo APBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO and sirolimus PO beginning on day -3 and continuing for up to 6 months with taper. rituximab: Given IV fludarabine phosphate: Given IV melphalan: Given IV sirolimus: Given PO tacrolimus: Given PO or IV allogeneic hematopoietic stem cell transplantation: Undergo APBSCT indium In 111 ibritumomab tiuxetan: Given IV yttrium Y 90 ibritumomab tiuxetan: Given IV
id
EG000
other Num Affected
41
other Num At Risk
41
serious Num Affected
28
serious Num At Risk
41
title
0.4 mCi 90Y-Ibritumomab Tiuxetan

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
14
num At Risk
41
num Events
20
term
Bone marrow cellularity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
DIC (disseminated intravascular coagulation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
19
num At Risk
41
num Events
21
term
Edema:head and neck
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
35
num At Risk
41
num Events
51
term
Edema:limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
num Events
5
term
Edema:trunk/genital
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
num Events
5
term
Haptoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
term
Hematoma
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
41
num At Risk
41
num Events
126
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
num Events
9
term
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
22
num At Risk
41
num Events
31
term
Hemorrhage, GI
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
20
num At Risk
41
num Events
24
term
Hemorrhage, GU
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
20
num At Risk
41
num Events
22
term
Hemorrhage, pulmonary/upper respiratory

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Chyle or lymph leakage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Hemorrhage, GI
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Hemorrhage, pulmonary/upper respiratory
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Thrombosis/embolism (vascular access-related)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
3
num At Risk
41
num Events
4
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Myocarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Pericardial effusion (non-malignant)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Ascites (non-malignant)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
term
Dehydration

time Frame

From initial treatment to off study, up to 5 years.

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Preserved source evidence · Not medical advice