NCT02145039 · ADVERSE EVENTS

Adverse events

Reduced Intensity Conditioning and Haploidentical Related Bone Marrow for Patients With Hematologic Diseases · Source last updated 2019-12-26

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: 2 years post-transplant
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Haploidentical Stem Cell Transplant This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion	0 / 2	0 / 2	2 / 2

Group identifiers: EG000: Haploidentical Stem Cell Transplant

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.

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
2
description
This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
id
EG000
other Num Affected
0
other Num At Risk
2
serious Num Affected
0
serious Num At Risk
2
title
Haploidentical Stem Cell Transplant

frequency Threshold

time Frame

2 years post-transplant

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice