NCT00245037 · ADVERSE EVENTS

Adverse events

Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer · Source last updated 2017-09-27

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: Non-hematologic toxicities and adverse experiences ≥ Grade 3 will be assessed up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI) Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including	59 / 147	52 / 147	Not reported / Not reported

Group identifiers: EG000: Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)

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
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
147
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
147
term
Atrial fibrillation/flutter
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Respiratory pulseless electrical activity (PEA) arrest
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Event associated with CsA
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Cryptogenic organizing pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Eosinophilic pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
147
term
CsA toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
147
term
Posterior-reversible encephalopathy syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Veno-occlusive disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Iron overload

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
notes
Unrelated to Regimen
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
14
num At Risk
147
term
Neutropenic fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
38
num At Risk
147
term
Hyperbilirubinemia or transaminitis

Complete source fields

event Groups

description
Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0 Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species. Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative. IV Busulfan is available and diluted and administered per package insert guidelines. Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including
id
EG000
other Num Affected
52
other Num At Risk
147
serious Num Affected
59
serious Num At Risk
147
title
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Unrelated to Regimen
organ System
Infections and infestations
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
14
num At Risk
147
term
Neutropenic fever
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
38
num At Risk
147
term
Hyperbilirubinemia or transaminitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Left ventricular systolic dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
147
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
3
num At Risk
147
term
Atrial fibrillation/flutter
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Left ventricular dysfunction
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Respiratory pulseless electrical activity (PEA) arrest
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Renal and urinary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Event associated with CsA
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Cryptogenic organizing pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Eosinophilic pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
5
num At Risk
147
term
CsA toxicity
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Nervous system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
2
num At Risk
147
term
Posterior-reversible encephalopathy syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
Hepatobiliary disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Veno-occlusive disease
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Related to regimen
organ System
General disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
147
term
Iron overload

time Frame

Non-hematologic toxicities and adverse experiences ≥ Grade 3 will be assessed up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant.

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Preserved source evidence · Not medical advice