NCT01300572 · ADVERSE EVENTS

Adverse events

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS · Source last updated 2019-12-10

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 (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician.
Other-event reporting threshold: 5%

Non-hematologic adverse events of ≥ grade 3, possibly related events of grade 2 that have not previously been observed with components of the study regimen, and all serious adverse events will be captured in protocol-specific case report forms. Beyond day +100, disease progression, development of secondary malignancies, and survival only will be collected.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant) PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.	9 / 15	11 / 15	5 / 15

Group identifiers: EG000: Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

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
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
7
num At Risk
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Cellulitis
organ System
Infections and infestations
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Headache

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) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
6
num At Risk
15
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Mucositis, oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
9
num At Risk
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Stomach pain

Complete source fields

description

event Groups

deaths Num Affected
5
deaths Num At Risk
15
description
PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0.
id
EG000
other Num Affected
11
other Num At Risk
15
serious Num Affected
9
serious Num At Risk
15
title
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Chest pain - cardiac
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Pericarditis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
3
num At Risk
15
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
6
num At Risk
15
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Dry mouth
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
2
num At Risk
15
term
Mucositis, oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
9
num At Risk
15
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Stomach pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
7
num At Risk
15
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Anorexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Oral pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Cellulitis
organ System
Infections and infestations
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Hypokalemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE) Version 4.0
stats
group Id
EG000
num Affected
1
num At Risk
15
term
Headache

time Frame

Adverse events (AEs) will be monitored and recorded in study-specific case report forms (CRFs) from the time of first exposure to an investigational agent (i.e., the start of the Indium-111-DOTA-BC8 infusion) through day +100 after transplant or through discharge prior to that date from the SCCA system to the care of the patient's primary physician.

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Preserved source evidence · Not medical advice