NCT01076270 · ADVERSE EVENTS

Adverse events

Plerixafor and Filgrastim For Mobilization of Donor Peripheral Blood Stem Cells Before A Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2017-06-28

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 the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Filgrastim and Plerixafor for PBSC Mobilization Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation. plerixafor: Given SC filgrastim: Given SC peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells	0 / 1	1 / 1	1 / 1

Group identifiers: EG000: Filgrastim and Plerixafor for PBSC Mobilization

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Lightheadedness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Flatulence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Bone pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Fatigue

Complete source fields

event Groups

deaths Num Affected
1
deaths Num At Risk
1
description
Donors receive filgrastim subcutaneously (SC) and plerixafor SC on day -14 and undergo leukapheresis to collect peripheral blood stem cells (PBSC) on day -13. These cells are frozen to preserve them. Treatment modifications may apply according to sufficient collection of PBSC. Patients receive standard high-dose conditioning and undergo allogeneic PBSC transplantation on day 0 using the previously frozen cells. After completion of study treatment, donors are followed up 1 day after the last stem cell donation. plerixafor: Given SC filgrastim: Given SC peripheral blood stem cell transplantation: Infusion of peripheral blood stem cells allogeneic hematopoietic stem cell transplantation: Infusion of hematopoietic stem cells
id
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
0
serious Num At Risk
1
title
Filgrastim and Plerixafor for PBSC Mobilization

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Lightheadedness
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Flatulence
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Diarrhea
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Bone pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Headache
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
term
Fatigue

time Frame

From the first dose of study drug to one week after the last clinic visit. The last clinic visit typically occurs the day after stem cell collection is completed.

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Preserved source evidence · Not medical advice