NCT00698685 · ADVERSE EVENTS

Adverse events

Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation · Source last updated 2017-03-31

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 event data for this study was collected from January 23, 2006 to April 13, 2009.
Other-event reporting threshold: 5%

Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Preparative Regimen of Pentostatin and Alemtuzumab Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT. Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.	8 / 13	13 / 13	Not reported / Not reported

Group identifiers: EG000: Preparative Regimen of Pentostatin and Alemtuzumab

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
These blood chemistries returned to normal within several days after cessation of pentostatin infusion and without specific intervention: probably associated with the infusion of pentostatin.
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
metabolic/laboratory: elevated AST and ALT
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Developed about 50 days after unrelated PBPCT;required hospital stay for continuous bladder irrigation and transfusions of red cells and platelets; also had elective cystoscopy, at which time clot was evacuated from the bladder. Possibly related.
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
hemorrhagic cystitis associated with BK virus
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Occurred without evidence of donor engraftment. subject had comorbidities \[i.e., coronary artery disease\] died with multisystem failure. Assessed as expected SAE and was possibly related.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
hypoxia and dyspnea which was a result of pulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
notes
After extensive evaluation, determined subject had disseminated toxoplasmosis. Subject died shortly after initiation of definitive therapy for toxoplasmosis. Assessed expected SAE \[infections\] and possibly related to investigational treatment.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
altered mental status and progressive obtundation [disseminated toxoplasmosis]
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Due to progressive hepatic infiltration by Hodgkin's disease and felt to be an expected SAE that was related to subject's aggressive underlying malignancy and unrelated to investigational treatment.
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject had persistent fevers and disseminated toxoplasmosis determined by quantitative PCR on a blood sample. Assessed as expected SAE (infections)and possibly related to investigational treatment.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
disseminated toxoplasmosis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Developed in May 2009 about 6 months after administration of investigational treatment and required hemodialysis. Assessed as expected SAE and unrelated to the investigational treatment.
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Cardiac and respiratory failure.
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Death on study, post BMT

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
5
num At Risk
13
num Events
63
term
Blood/Bone Marrow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
DIC (disseminated intravascular coagulation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
10
term
Cardiac General
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Cardiac Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
9
term
Edema: limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Edema: viscera
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Fibrinogen
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
36
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
8
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
17
term
Lymphatics
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Neutrophils/granulocytes (ANC/AGC)

Complete source fields

description

Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.

event Groups

description
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT. Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
id
EG000
other Num Affected
13
other Num At Risk
13
serious Num Affected
8
serious Num At Risk
13
title
Preparative Regimen of Pentostatin and Alemtuzumab

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
5
num At Risk
13
num Events
63
term
Blood/Bone Marrow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
DIC (disseminated intravascular coagulation)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
6
num At Risk
13
num Events
10
term
Cardiac General
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Cardiac Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
9
term
Edema: limb
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Edema: viscera
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Fibrinogen
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
36
term
Hemoglobin
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
8
term
Leukocytes (total WBC)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
8
num At Risk
13
num Events
17
term
Lymphatics
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (3.0)
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Neutrophils/granulocytes (ANC/AGC)

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
These blood chemistries returned to normal within several days after cessation of pentostatin infusion and without specific intervention: probably associated with the infusion of pentostatin.
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
metabolic/laboratory: elevated AST and ALT
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Developed about 50 days after unrelated PBPCT;required hospital stay for continuous bladder irrigation and transfusions of red cells and platelets; also had elective cystoscopy, at which time clot was evacuated from the bladder. Possibly related.
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
hemorrhagic cystitis associated with BK virus
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Occurred without evidence of donor engraftment. subject had comorbidities \[i.e., coronary artery disease\] died with multisystem failure. Assessed as expected SAE and was possibly related.
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
hypoxia and dyspnea which was a result of pulmonary hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
notes
After extensive evaluation, determined subject had disseminated toxoplasmosis. Subject died shortly after initiation of definitive therapy for toxoplasmosis. Assessed expected SAE \[infections\] and possibly related to investigational treatment.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
altered mental status and progressive obtundation [disseminated toxoplasmosis]
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Due to progressive hepatic infiltration by Hodgkin's disease and felt to be an expected SAE that was related to subject's aggressive underlying malignancy and unrelated to investigational treatment.
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
hyperbilirubinemia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Subject had persistent fevers and disseminated toxoplasmosis determined by quantitative PCR on a blood sample. Assessed as expected SAE (infections)and possibly related to investigational treatment.
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
disseminated toxoplasmosis
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Developed in May 2009 about 6 months after administration of investigational treatment and required hemodialysis. Assessed as expected SAE and unrelated to the investigational treatment.
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Cardiac and respiratory failure.
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Death on study, post BMT

time Frame

Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.

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Preserved source evidence · Not medical advice